Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for Analyst Regulatory Affairs Consultant with Hybrid option for 12 months CONTRACT and renewable, to join one of our major consumer products clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. 

Position Summary

Ensures proper submission and approvals for market licenses including new registrations, changes and timely renewals, and establishment registrations, organizing and balancing a multitude of projects simultaneously.

• Elaborate regulatory strategy and execute submission of changes, new registrations and renewals in timely manner with some guidance.
• Execute activities to obtain or update establishment registration licenses.
• Execute post-approval activities such as preparation of communications to stakeholders, labels and Instructions for Use and system updates.
• Request and follow-up of documentation to prepare registration dossiers.
• Supports regional team on product submissions schedules, prioritization, and pipeline management.
• Support internal and external audits with documentation requests.
• Interacts with other JJ stakeholders, government agencies in a professional, decisive, & articulate manner.
• Act as a point of contact for stakeholders to support business plans and regulatory needs.
• Review labels compliance in internal system.

• Support projects as representative of the subject/country.
• Elaborate procedures of the area.
• Organize team meetings and elaborate agenda and minutes.
• Manage quality issues.
• Manage compulsory certification (INMETRO) and GMP activities.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Regulatory Affairs, Consultant

#LI-PB1 #LI-Hybrid #Contract

Primary Responsibilities:

• Provides administrative and operational support to the TA team.
• Supports the TA team in the administration and maintenance of the Applicant Tracking System.
• Supports the TA team in managing job postings.
• Reviews resumes and applications to identify qualified candidates who meet the hiring criteria.
• Schedules initial phone screens, in-person interviews or virtual interviews to assess candidates' qualifications and suitability for the role.
• Other TA related projects/tasks as assigned.
• Maintain confidentiality of HR information.

Candidate Profile:

• Bachelor’s degree required or a combination of education, experience, and/or skills.
• 2-3 years of experience in candidate recruiting.
• Proficient in MS Office (Word, Excel, Outlook).
• Strong verbal and written communication skills.
• Strong interpersonal, negotiation, and communication skills.
• Ability to work under tight timelines.
• Ability to interface and communicate with all levels of the organization.
• Ability to be discreet and handle confidential, sensitive information.
• Good verbal and written language skills in English.
• Must be a self-starter, problem-solver, and one who is able to work in a fast-paced environment.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...

ClinChoice is searching for a Clinical R Programmer Consultant to join one of our clients. 

We are seeking a Clinical R Programmer with strong experience in R and a solid background in clinical programming. The ideal candidate will have hands-on experience developing SDTM and ADaM datasets using R, along with working knowledge of SAS. This role requires someone who can support clinical trial deliverables, ensure regulatory compliance, and collaborate closely with biostatistics and clinical data teams.

Key Responsibilities

• Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards.
• Support TLF (Tables, Listings, Figures) generation in R or SAS as needed.
• Write efficient, reproducible, and well-structured R scripts for clinical data analysis and reporting.
• Collaborate with statisticians, data managers, and clinical teams to understand programming requirements.
• Perform QC checks, reconcile data issues, and ensure deliverables meet regulatory expectations (e.g., FDA, EMA).
• Contribute to programming workflows, documentation, and version control best practices.
• Support automation initiatives and R-based pipeline development.
• Utilize SAS for legacy studies or where SAS support is required.

Required Qualifications

• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
• 4–6+ years of experience in clinical programming, with a strong focus on R.
• Proven experience in creating SDTM and ADaM datasets using R.
• Working knowledge of SAS programming.
• Solid understanding of CDISC standards (SDTM, ADaM).
• Experience with clinical trial data, regulatory submissions, and QC processes.
• Strong analytical, problem-solving, and documentation skills.

Preferred Qualifications

• Experience with R packages such as tidyverse, haven, pharmaverse (e.g., admiral, tidyCDISC), or other clinical programming toolkits.
• Understanding of R Markdown, Shiny apps, or reproducible reporting tools.
• Exposure to GxP validation, version control (Git), and automated workflows.
• Experience working in a CRO or pharmaceutical environment.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our low industry-average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-#TT1 #LI-Remote #Senior#Contract

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are recruiting for a Business Development Director to join our internal team in Germany. You will be responsible for selling CRO full services. Additional tasks include lead generation, opportunity assessment, creating new accounts and growing existing accounts. This is a full-time permanent opportunity. Previous experience working with a global Contract Research Organization and selling full CRO services is required (mandatory).

Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities: 

• Identify, assess, and pursue new business opportunities.
• Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations.
• Develop a deep appreciation for the client's business challenges and organizational structure and use this insight to develop realistic and actionable account plans.
• Contribute to the ongoing refinement of the company's business development approach, defining client and vertical targets, minimizing the cost of sales, and increasing both efficiencies and closing rates.
• Work to exceed revenue targets that align with the company's growth objectives.

Education, Experience and Skills:

• 6+ years of sales and account management experience selling
• Previous experience selling CRO full services (mandatory)
• Established a network of decision-makers in the life-sciences industry.
• Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders.
• Strong negotiation skills with a proven track record of closing complex business deals
• Persuasive and compelling presentation and communication skills, both written and verbal
• Ability to interpret business challenges and present quick and responsive high-level solutions.
• Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle.
• Positive employer and client references
• BA, MBA, or equivalent experience

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Director of Business Development, business development, marketing, contracting, travel, clinical trials, CRO, Clinical Research Organization, clinical development, CRO management, relationship management, clinical research sales, account management, CRO full-service sales

#LI-LG1 #LI-Remote #LI-Director #LI-FULLTIME

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...

ClinChoice is currently recruiting for a Senior Statistical Programmer to join our team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment.

Responsibilities

Programing for clinical trials:
Program and validate derived datasets, tables, figures, listings. Process data from the external sources.  
Perform ad hoc exploratory analyses for publications and programming support other functions of Research and Development or other organizations.
Oversee programing work/deliverables from CROs.
Contribute to the design/implementation/review of Case Report Form, Data Transfer Specification, Statistical Analysis Plan, SDTM/ADaM Specification documents, Define packages.

Electronic submissions:
Program and validate CDISC compliant deliveries for the electronic submissions.
Support in the creation of supporting documentation for submissions.

Project Management:
Ensure programming deliverables are on time and of high quality.
Help managing internal contractors and external vendors.

Standards and Guidelines:
Participate in development of departmental working instructions and guidelines.
Help in creation of enhanced functions/macros and utilities.  

Qualification & Experience 

• Bachelor or Master degree in Computer Science, Mathematics, Engineering, Medical or related discipline.
• BS with more than 5 or MS with 3 years of experience in statistical programming (SAS, R) in the pharmaceutical industry.
• Working knowledge of SAS and its various components.
• Knowledge of R programming in clinical trials
• Familiarity of the drug development process.
• Strong SAS and SAS Macro language skills.
• R programming skils in clinical trials
• Strong knowledge of industry standards.
• Ability to work on data integrations (ISS and ISE).
• Strong oral and written communication skills. Ability to communicate details of the analysis to other team members with less technical experience.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #senior#contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...

ClinChoice is currently recruiting for a Statistical Programmer II/III to join our team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment.

Job Summary:
We are seeking an experienced Statistical Programmer III with strong expertise in R programming to support clinical trial data analysis and reporting. The ideal candidate will have hands-on experience in developing, validating, and maintaining statistical outputs using R, along with a solid understanding of clinical data standards.

Key Responsibilities:

• Develop, validate, and maintain statistical programs using SAS for the generation of Tables, Listings, and Figures (TLFs)
• Perform data manipulation, analysis, and visualization using R/SAS and relevant packages
• Collaborate with Biostatisticians and Data Management teams to support clinical study deliverables
• Ensure compliance with regulatory standards and company SOPs
• Conduct quality control (QC) and validation of programming outputs
• Support submission activities and documentation as required

Required Skills & Qualifications:

• Bachelor’s or Master’s degree in Statistics, Biostatistics, Computer Science, or a related field
• 3+ years of experience in statistical programming within the pharmaceutical/biotech industry
• Hands-on experience with R programming in a clinical trial environment
• Good understanding of R packages. 
• Good understanding of CDISC standards (SDTM, ADaM)
• Strong knowledge of clinical trial data and regulatory requirements

Preferred Qualifications:

• Experience working in an FSP model or with global pharmaceutical clients
• Exposure to submission activities (e.g., FDA/EMA)
• Familiarity with SAS alongside R is a plus
• Strong problem-solving and communication skills

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #senior#contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...

ClinChoice is currently recruiting for a Clinical Data Manager to join our team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment.

Role Overview:

We are seeking a detail-oriented Clinical Data Manager with 3–5 years of experience in a CRO or pharmaceutical environment. The role involves managing clinical trial data to ensure accuracy, integrity, and compliance with regulatory standards.

Key Responsibilities:

• Manage end-to-end clinical data management activities for assigned studies
• Design and review CRFs (Case Report Forms) and edit checks
• Oversee data collection, cleaning, and validation processes
• Perform data review and discrepancy management
• Coordinate with cross-functional teams (Clinical, Biostatistics, Programming)
• Ensure compliance with CDISC standards and regulatory guidelines
• Support database build, UAT testing, and database lock activities
• Generate and review data listings and reports
• Participate in data reconciliation (e.g., SAE, lab data)
• Ensure timely delivery of high-quality datasets for analysis and submission

Required Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field
• 3–5 years of experience in clinical data management within CRO/pharma
• Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Inform)
• Strong understanding of GCP, ICH guidelines, and clinical trial processes
• Familiarity with CDISC standards (SDTM)
• Good knowledge of data validation and query management
• Strong attention to detail and problem-solving skills

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Senior #Permanent

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for an Senior Biostatistician Consultant to join one of our clients in V&I (Vaccines & Infectious disease ) department 

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Role Overview:

We are seeking an experienced Senior Statistician Consultant to support clinical development programs within the Vaccines & Infectious Diseases (V&I) therapeutic area. The role involves leading statistical strategy, analysis, and reporting for clinical trials, ensuring high-quality deliverables aligned with regulatory standards.

Key Responsibilities:

• Lead statistical input for clinical trial design, including protocol development and sample size calculations
• Develop and review Statistical Analysis Plans (SAPs)
• Provide oversight of statistical analyses for clinical studies (Phase I–IV)
• Collaborate with cross-functional teams including Clinical, Data Management, and Programming
• Interpret study results and contribute to clinical study reports (CSRs)
• Support regulatory submissions (e.g., FDA, EMA) including responses to health authority queries
• Guide and review work of statistical programmers (SDTM/ADaM, TLFs)
• Ensure compliance with CDISC standards and regulatory guidelines
• Participate in safety and efficacy analyses, including interim analyses
• Provide strategic input for ISS/ISE and integrated analyses

Required Qualifications:

• Master’s or PhD in Statistics, Biostatistics, or related field
• 5+ years of experience in clinical trials within pharma/CRO
• Strong experience in Vaccines & Infectious Diseases
• In-depth knowledge of clinical trial methodology and statistical principles
• Experience with regulatory submissions (FDA/EMA)
• Proficiency in SAS; knowledge of R is a plus
• Strong understanding of CDISC (SDTM/ADaM) standards
• Excellent communication and stakeholder management skills

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Senior#Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...

ClinChoice is currently recruiting for a Senior Statistician to join our team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment.

Job Summary

We are seeking a highly skilled Senior Statistician to support and lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams.

Key Responsibilities

• Lead and provide statistical support for clinical studies, primarily within Immunology or any therapeutic areas

• Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables

• Author and review key statistical documents, including:

  • Statistical Analysis Plans (SAPs)

  • Analysis Database Specifications (ADS)

  • Statistical sections of clinical study reports

• Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance

• Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory

• Provide guidance and oversight to statistical programmers as needed

• Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders

• Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs

Required Qualifications

• MS or PhD in Statistics, Biostatistics, or a related field

• Strong experience in Immunology or any TA clinical studies 

• Hands-on experience writing:

  • Statistical Analysis Plans (SAPs)

  • Analysis Database Specifications

  • Reviewing and interpreting analysis results

• SAS programming skills required (hands-on or strong working knowledge)

• Excellent written and verbal communication skills

• Experience working in a CRO and/or pharmaceutical/biotech environment

Preferred Qualifications

• Experience leading Phase II–III clinical trials

• Prior interaction with regulatory agencies

• Experience mentoring junior statisticians or programmers

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Senior #Permanent

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Main Job Tasks and Responsibilities: 

The Senior Statistical Programmer Consultant is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks

Key Responsibilities: 

• Responsible for supporting the Programming deliveries of a clinical study or project.
• Implements statistical programming aspects of the protocol and the clinical development program.
• Ensures high quality is built into own deliverables and the quality delivered by other programmers.
• Programs independently with high efficiency and quality.
• Writes and/or implements specifications and oversees completeness of relevant documentation.
• Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
• Ensures compliance with standards and automation usage.
• Plans and support team activities and tasks.
• Communicates and escalates risks within the assigned studies and/or projects.
• Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.

Education and Experience:

• Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
• Need to have Oncology TA experience.
• Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
• Good understanding of the clinical drug development process.
• Strong communication skills and coordination skills.
• Current knowledge of technical and regulatory requirements relevant for the role
• Ability to proactively manage concurrent activities within a project
• Proficient ability to influence relevant stakeholders on programming-related items

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Senior #Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a CMC Strategist Consultant with Remote option in CANADA for 12 months CONTRACT and renewable, to join one of our major consumer products clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. 

Position Summary

We are seeking a Regulatory Strategist – CMC to support global regulatory strategy and execution across the product lifecycle. This role will be responsible for developing and implementing CMC regulatory strategies, preparing and reviewing high-quality regulatory submissions, and supporting post-approval activities for U.S. FDA and Health Canada. The ideal candidate brings strong technical CMC knowledge, hands-on submission experience, and the ability to partner cross-functionally with CMC, Quality, and Manufacturing teams.

Key Responsibilities

Regulatory Strategy & Planning
•    Develop and execute CMC regulatory strategies for new product development and product lifecycle management.
•    Support regulatory strategy planning and act as a key contributor to dossier planning for global submissions.
•    Provide regulatory input on CMC development activities, change management, and post-approval strategies.
Regulatory Submissions (U.S. FDA & Health Canada)
•    Support preparation and submission of CMC regulatory documents for new product filings to US FDA and Health Canada.
•    Compile, review, and manage Modules 1, 2, and 3 of U.S. regulatory dossiers.
•    Review CMC documentation and perform DMF assessments, including coordination with DMF holders as needed.
Post-Approval Activities
•    Manage post-approval submissions to US FDA, including:
o    Major and Moderate CMC amendments
o    Administrative amendments
o    DMF amendments
o    Annual Reports
•    Lead and coordinate timely responses to FDA Information Requests (IRs) and Complete Response Letters (CRLs).
•    Support post-approval submissions to Health Canada, including compilation and submission of Annual Notifications and Supplements.
Change Control & Compliance
•    Assess and manage Global Change Controls (GCCs) to determine regulatory impact and required filings.
•    Support preparation and review of Annual Product Reports (APRs).
•    Ensure compliance with applicable regulatory guidelines, policies, and global CMC requirements.

Required Qualifications

•    Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology, or a related discipline (advanced degree preferred).
•    3+ years of experience in CMC regulatory affairs within pharmaceutical, biotech, or CDMO environments.
•    Hands-on experience with U.S. FDA and Health Canada CMC submissions across the product lifecycle.
•    Strong working knowledge of ICH guidelines, FDA regulations, and Health Canada requirements.
•    Experience compiling and reviewing Modules 1–3 and working with Drug Master Files (DMFs).
•    Proven ability to manage multiple submissions and timelines in a fast-paced environment.

Preferred Skills & Competencies

•    Strong analytical and problem-solving skills.
•    Excellent written and verbal communication abilities.
•    Ability to work cross-functionally and influence stakeholders.
•    High attention to detail with a quality- and compliance-focused mindset.
•    Experience with global regulatory strategies beyond North America is a plus.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Regulatory CMC. 

#LI-PB1 #LI-Remote #Contract

AI: 

Our hiring process includes AI screening for keywords and minimum qualifications. Recruiters review all results. 

Vacancy: 

This posting is for an existing vacancy. 

Open Date: 4/24/2026

Close Date: 6/8/2026

The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following & delete these instructions):

ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity.  We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301. 

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for an Associate, Supply Chain Material Coordinator to join one of our partner companies, a large pharmaceutical company in Belgium. This is an office-based role, in Mont Saint-Guibert, Belgium.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

The Supply Chain Material Coordinator is responsible for the coordination and procurement of packaging materials and drug product for Clinical Trial Materials. The CT function has the responsibility for the ordering, manufacturing, packaging, shipment, and inventory management of supplies for clinical studies worldwide. The organization produces custom-designed trial materials under full GMP regulations.

Main Job Tasks and Responsibilities:

• Accountable for MRP actions from the point of purchase order or stock transfer order creation through successful batch disposition.
• Participate in material movement planning meetings.
• Own all order fulfilment activities from customer request through material delivery including documentation, delivery schedule, and priorities.
• Responsible for inventory management including disposition of expired materials.
• Promptly address inquiries received from CPs.
• Provide operations support to the FING Packaging Plant Planning function.
• Troubleshoot and resolve purchasing, material fulfilment or operational level issues as they arise.
• Identify and participate in projects or assignments to improve productivity, compliance, and data accuracy.
• Author deviations, change controls and perform investigations as necessary
• Managing vendor relationships and issue resolution.
• KPI’s and metrics generation.

Education and Experience:

• B.S. in Pharmacy, Pharmaceutical Sciences, Chemical/Biochemical Engineering or related field / experience.
• Experience in managing inventory/supplies or complex supply chains.
• Knowledge of clinical trial packaging.
• Demonstrated exemplary teamwork/interpersonal skills.
• Strong organization and self-management skills.
• Ability to use and apply multiple computer applications.
• Ability to manage multiple tasks and respond to change.
• Effective written and verbal communication skills in multi-cultural settings.
• High initiative, flexible and positive attitude.
• High degree of accuracy with work and attentive to details.
• Ability to proactively identify problems and work toward a solution.
• Minimum 1 year in a GMP environment.

Additional Preferences:

• Clinical research/study knowledge.
• Prior experience with SAP is preferred.
• Data analysis and Excel experience.
• Fluent in English language.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Associate Supply Chain, Clinical Trial, Labelling, Shipment, Packaging, GMP, English, CRO, Contract Research Organization, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #TEMPORARY

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for an Senior/Principal Biostatistician-Medical Affairs Consultant to join one of our clients. 

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. 

Summary

We are seeking a highly skilled Senior Statistician to support Medical Affairs activities, including post-marketing studies, real-world evidence (RWE) generation, and observational research. This role will partner closely with cross-functional teams to provide statistical expertise and ensure high-quality data analysis and interpretation.

ey Responsibilities

• Provide statistical support for Medical Affairs studies, including:
  • Observational studies
  • Real-world evidence (RWE) studies
  • Post-marketing and Phase IV studies
• Contribute to study design, protocol development, and statistical analysis plans (SAPs)
• Perform and/or oversee statistical analyses and ensure accuracy and quality of outputs
• Collaborate with Medical Affairs, Clinical, Epidemiology, and HEOR teams
• Interpret study results and contribute to clinical study reports, publications, and presentations
• Ensure compliance with regulatory and internal standards
• Support publication strategy and scientific communication activities
• Mentor junior statisticians, if applicable

Qualifications

• Master’s or PhD in Statistics, Biostatistics, or a related field
• 5–8+ years of relevant experience in the pharmaceutical, biotech, or CRO industry
• Strong experience in Medical Affairs / RWE / observational studies
• Proficiency in SAS and/or R
• Experience with study design, statistical modeling, and data interpretation
• Knowledge of regulatory guidelines and industry standards

Preferred Qualifications

• Experience in Immunology / Oncology / relevant therapeutic area
• Prior experience supporting publications and external communications
• Strong stakeholder management and communication skills

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Senior#Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Quality Engineer SM-API to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Geel, office, until the end of December 2026.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

Within Supply Chain Quality (SCQ) Geel, as a Quality Engineer SM-API, you are a key partner for Operations and Quality. You provide quality advice, review GMP documentation, and oversee the handling of non-conformances and corrective/improvement actions so that the timely release of our commercial API product portfolio can be achieved in compliance with applicable regulations.

Main Job Tasks and Responsibilities:

• Review and approval of non-conformances and CAPAs in support of the QA commercial Operations team.
• Review and approve GMP documentation such as procedures, work instructions, protocols and reports.
• Provide quality support to the production plants.
• Ensure that quality records (e.g., Change Controls) are processed on time and in compliance by providing quality, compliance and technical expertise.
• Participate in QA check rounds.
• Support for smaller optimization projects and tasks within the QA Commercial Operations team.
• Establish and maintain strong working relationships with Business and Quality partners.
  

Education and Experience:

• Master Scientific degree (chemistry, pharmaceutical sciences, bioengineer).
• Experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance and experience as release responsible is an asset.
• Experience in non-conformance handling is a must.
• In-depth understanding of pharmaceutical product development, qualification, validation, manufacturing, packaging, labelling, testing, release, storage and distribution processes.
• Demonstrated ability to work independently while staying connected with key stakeholders.
• Strong analytical and solution-oriented mindset; able to work flexibly under time pressure.
• Ability to make risk-based decisions under time pressure.
• In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
• Experience with Quality Systems.
• Fluent in English and Dutch (spoken and written).

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Engineer SM-API, Quality Assurance, Supply Chain, GMP, CAPA, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #LI-TEMPORARY

The HR Manager will lead the end-to-end Human Resources in ensuring HR operations, talent acquisition, employee relations, compensation/benefits, compliance, and people development are executed at a high standard. This role partners closely with functional leaders supporting clinical operations and corporate teams, and provides support to the office administration team to ensure smooth and compliant workplace experience

This role reports to the Vice President, Human Resources, APAC and will have direct reports in Human Resources, Talent Acquisition and Administration teams.

Primary Responsibilities:

1. End-to-End HR Operations & HR Business Partnership:

• Own the full employee lifecycle: workforce planning, hiring, onboarding, performance management, development, engagement, and offboarding. 
• Act as a strategic HR partner to leaders—advising on org design, role clarity, resource planning, and employee performance.
• Maintain HR policies, employee handbook, and SOPs aligned with company standards and local labour requirements
• Drive HR service delivery excellence (timeliness, accuracy, employee experience) and continuous improvement of HR processes
• Oversee payroll inputs/coordination and ensure accurate processing (in partnership with Finance or payroll vendor).
• Manage Administration of benefits programs and vendor relationships (HMO, life insurance, wellness offerings); manage enrolment and employee queries.
• Ensure accurate maintenance of employee records, HRIS data integrity, and reports (headcount, attrition, leaves, recruitment metrics).
• Manage contracts, job offers, employment letters, policy acknowledgments, and employee file compliance.

2. Talent Acquisition and Recruitment:

• Manage end-to-end recruitment for technical and corporate roles including (but not limited to): Clinical Research Associates, Project Managers, Data Management, Biostatistics, Pharmacovigilance, Regulatory, QA, Finance, and Admin.
• Build effective sourcing strategies: LinkedIn sourcing, job boards, referral programs, partnerships with universities/professional groups, and niche recruitment channels.
• Ensure consistent hiring practices: job scoping, competency-based interviews, assessment coordination, offer management, and background checks.
• Provide market insights on salary benchmarks and talent availability to support competitive hiring decisions.
• Maintain an organized pipeline and track recruiting metrics: time-to-fill, offer acceptance rate, source effectiveness, quality-of-hire indicators.

3. Performance Management, Learning & Development

• Lead performance management cycles (goal setting, mid-year reviews, annual evaluation, calibration support where applicable).
• Identify training needs and implement L&D programs aligned with business objectives.
• Support development planning and career progression frameworks for critical roles.

4. Employee Relations and Labor Compliance:

• Handle employee relations cases: coaching leaders, conflict resolution, investigations, and documentation of disciplinary actions with due process.
• Ensure compliance with Philippine labor standards and statutory requirements (e.g., DOLE, SSS, PhilHealth, Pag-IBIG, BIR where applicable).
• Manage grievance handling and promote a fair, consistent, and respectful workplace culture.
• Lead HR risk mitigation through proper documentation, recordkeeping, and policy adherence.

5. HR Compliance:

• Partner with Quality Assurance/Compliance to align HR practices with regulated industry expectations (e.g., training documentation, competency tracking, audit readiness).
• Maintain training matrices and onboarding compliance and processes.
• Ensure HR processes are audit-ready (organized records, evidence of training, policy compliance).

Secondary Responsibilities:

HR Manager provides functional guidance and oversight; day-to-day execution may sit with Office Admin.

• Support Office Admin in facilities operations: vendor management, office supplies, maintenance coordination, and workplace safety initiatives.
• Review/approve office-related processes that intersect with HR compliances.
• Coordinate office onboarding logistics (workstation readiness, access badges, office orientation) with Admin and IT.
• Provide input on office policies that impact employee experience (hybrid work arrangements, workplace etiquette, security practices).
• Support business continuity readiness for people-related components (emergency contacts, employee communication trees, evacuation/incident protocols).

Required Qualifications and Background:

• Bachelor’s degree in Human Resources, Psychology, Business Administration, or related field. Preferably with HR certifications or postgraduate units completed.
• 4-6 years of progressive HR experience with responsibilities including a lead/manager capacity.
• Demonstrated strength in Recruitment / Talent Acquisition (end-to-end), including technical roles and high-volume or niche hiring. Experience in CRO, Health and Pharmaceutical industries is a plus.
• Solid working knowledge of Philippine labour practices, employee relations, and statutory requirements.
• Has good grasp using MS Office Suites and HRIS Systems.
• Experience managing HR operations: onboarding/offboarding, benefits, payroll coordination, HR documentation, and policy implementation.
• Strong stakeholder management skills—able to influence leaders and handle sensitive matters with discretion.
• Excellent Oral and Written communications skills.

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are recruiting for a Business Development Director to join our internal team in France. You will be responsible for selling CRO full services. Additional tasks include lead generation, opportunity assessment, creating new accounts and growing existing accounts. This is a full-time permanent opportunity. Previous experience working with a global Contract Research Organization and selling full CRO services is required (mandatory).

Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities: 

• Identify, assess, and pursue new business opportunities.
• Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations.
• Develop a deep appreciation for the client's business challenges and organizational structure and use this insight to develop realistic and actionable account plans.
• Contribute to the ongoing refinement of the company's business development approach, defining client and vertical targets, minimizing the cost of sales, and increasing both efficiencies and closing rates.
• Work to exceed revenue targets that align with the company's growth objectives.

Education, Experience and Skills:

• 6+ years of sales and account management experience selling
• Previous experience selling CRO full services (mandatory)
• Established a network of decision-makers in the life-sciences industry.
• Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders.
• Strong negotiation skills with a proven track record of closing complex business deals
• Persuasive and compelling presentation and communication skills, both written and verbal
• Ability to interpret business challenges and present quick and responsive high-level solutions.
• Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle.
• Positive employer and client references
• BA, MBA, or equivalent experience

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Director of Business Development, business development, marketing, contracting, travel, clinical trials, CRO, Clinical Research Organization, clinical development, CRO management, relationship management, clinical research sales, account management, CRO full-service sales

#LI-LG1 #LI-Remote #LI-Director #LI-FULLTIME

ClinChoice is recruiting for a Business Development Director to join our internal commercial team at our US headquarter location in Horsham PA. As a Business Development Director, you will focus on driving full clinical operations service growth by securing new clients and expanding services in existing clients to drive revenue growth.  You will be responsible for the full sales lifecycle – from prospecting, developing relationship, to closing all deals including complex, high value deals. Previous experience working with a global Contract Research Organization and selling full clinical operations services is required. Experience with developing clients with outsourcing exposure to China is a plus. The role offers a hybrid or remote work arrangement, depending on your location. This is a full-time, permanent position.

Main Job Tasks and Responsibilities

• Sales strategy and execution: Identify, assess, and develop new global full clinical service strategic plans. Implement realistic and actionable plans to achieve or exceed annual revenue goals that align with the company’s growth objective.
• Prospecting: Actively identify and secure new business opportunities and/or grow/expand services with existing clients.
• Relationship Management: Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations, including their Clinical Operations function, Outsourcing function, Procurement function, and C-Suite executives.
• Market Intelligence: Represent Company at key conferences, trade shows, and networking events to learn and monitor industry trends and competitor activities.
• CRM Management: Maintain all pipeline data promptly from prospecting to closing contracts in company CRM database.

Education, Experience and Skills

• 10+ years of sales or business development experience, with at least 6 years in global full service CROs.
• Established a network of decision-makers in the life-sciences industry.
• Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders.
• Strong negotiation skills with a proven track record of closing complex, multi-million-dollar business deals
• Persuasive and compelling presentation and communication skills, both written and verbal
• Ability to understand internal business need, interpret business challenges and present quick and responsive high-level solutions.
• Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle.
• Bachelor’s degree in Life Science, Biotechnology, or Business Administration; MBA is a plus.

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have 30 years of proven high-quality delivery and results across all our services with over 3,000 professionals in more than 20 countries across US, EU, APAC and ANZ. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Director of Business Development, business development, marketing, contracting, travel, clinical trials, CRO, Clinical Research Organization, clinical development, CRO management, relationship management, clinical research sales, account management, CRO full-service sales, Bid Defense, contract negotiations, business to business sales

#LI-VH1 #LI-Remote #LI-Director #LI-FULLTIME

Primary Responsibilities:

The Safety Surveillance Physician (Std.) will implement and support further development of proactive and systematic product surveillance strategies, by performing activities such as, but not limited to:

• Performance of alert triage within pre-defined timelines, by conducting systematic reviews of cases and aggregate data in the safety databases and reviewing trends, as applicable, to identify potential safety signals.
• Performance of signal validation and support for signal evaluation through the review, analysis, interpretation, and summary of case and aggregate safety data from various sources such as
  clinical, post marketing, observational studies, medical literature, health authority databases, and product quality databases.
• Assistance in the development and implementation of strategies for the surveillance of post-marketing data, as well as the development of product specific medical safety assessments.
• Participation as a member of the matrix teams to address product-specific safety issues.
• Support for the evaluation of novel and computer-assisted tools and methodologies for the analysis of safety data.
• Tracking of signal disposition and signal management activities in the relevant tracking tool.
• Support for maintenance of documentation relevant to signal detection and management activities.

Secondary Responsibilities:

• Effectively organize work to complete the assigned tasks to meet deadlines.
• Ensure the assigned tasks are delivered 100% on time or before, as per project SLA.
• Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work.
• Support in review of work done by peer teammates, on need basis.
• Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues encountered impacting the delivery schedule.
• Ensure error-free and acceptable quality in assigned deliverables.
• Responsible for ensuring training compliance and timesheet compliance.
• Ensure that all assigned goals [e.g. utilization and efficiency] are met as per set standards for the performance year.
• Be aware of and comply with the QMS/ ISMS & PIMS Policy.
• Report any potential or actual Security Breaches to the regional and/or global DPO & Security Incidents to CISO/ applicable distribution list.
• Contribute towards the achievement of Quality Objectives.

Candidate Profile:

• Board-certified Medical Physician
• Technical skills: Ability to analyze, interpret, and present complex data in a concise and understandable scientific manner, both orally and in written format.
• Attention to detail: Diligence in record-keeping and records organization, ability to manage a high workload and critical issues, computer-literate and proficient in MS Office applications.
• Interpersonal skills: team player, displays initiative, strong communication, and presentation skills
• Internal and external networking skills, strong collaborative and interpersonal skills, results-oriented and ability to independently create and deliver, ability to thrive in a global, cross-functional environment.
• Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. 

Location: 3 days hybrid at Malvern PA

Job Summary

The contract Senior Statistical Programmer is a member of the Biometrics Department within the Research and Development (R&D) organization who supports Statistical programming work in accordance with corporate standard operating procedures (SOPs), GCP, 21 CFR and ICH guidance.

Responsibilities

Programing for clinical trials:
Program and validate derived datasets, tables, figures, listings. Process data from the external sources.  
Perform ad hoc exploratory analyses for publications and programming support other functions of Research and Development or other organizations.
Oversee programing work/deliverables from CROs.
Contribute to the design/implementation/review of Case Report Form, Data Transfer Specification, Statistical Analysis Plan, SDTM/ADaM Specification documents, Define packages.

Electronic submissions:
Program and validate CDISC compliant deliveries for the electronic submissions.
Support in the creation of supporting documentation for submissions.

Project Management:
Ensure programming deliverables are on time and of high quality.
Help managing internal contractors and external vendors.

Standards and Guidelines:
Participate in development of departmental working instructions and guidelines.
Help in creation of enhanced functions/macros and utilities.  

Qualification & Experience 

• Bachelor or Master degree in Computer Science, Mathematics, Engineering, Medical or related discipline.
• BS with more than 5 or MS with 3 years of experience in statistical programming (SAS, R) in the pharmaceutical industry.
• Working knowledge of SAS and its various components.
• Knowledge of R programming in clinical trials
• Familiarity of the drug development process.
• Strong SAS and SAS Macro language skills.
• R programming skils in clinical trials
• Strong knowledge of industry standards.
• Ability to work on data integrations (ISS and ISE).
• Strong oral and written communication skills. Ability to communicate details of the analysis to other team members with less technical experience.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #senior#contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for an Principal Biostatistician Consultant to join one of our clients. 3 days Hybrid at Malvern PA. 

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. 

JOB SUMMARY:

This contract principal statistician will work with Biometrics director to manage one or more compounds/Indications in R&D for the entire life cycle. He/she will be responsible for all statistical aspects of the drug development and/or post-approval programs. These responsibilities include Regulatory interactions, study design, statistical methodology, analysis, regulatory submission, and/or pre- and post-approval activities.  He/she will coordinate statistical and programming support and will manage contractors/CROs when necessary. He/she will also serve as lead statistician for clinical studies and work with the study team  members effectively.

KEY ACCOUNTABILITIES:
Drug Development 

• Provide inputs to clinical team on the design, analysis and interpretation of scientific data from Phase I to IV clinical trials, ISS and ISE.
• Collaborate with the project team to design the protocols (synopses and full) and provide sample size calculations.
• Draft or review the SAP and the associated mock TLF.
• Performs review of TLFs to ensure that they are accurate within and across outputs for a particular deliverable (e.g., CSR, IDMC, publication).
• Provide statistical support for other functions within the organization (i.e.., Medical Affair, Regulatory, or others).
• Manage project timelines and interact with external vendors.

Communication:

• Conduct DAR meeting prior to database lock or Comment resolution meeting.
• Prepare the presentations and interpret the results.
• Participate in data review meetings within the organization.

Process Improvements:

• Be Compliant with all trainings and SOPs.
• Contributes to intra- and interdepartmental process improvement activities to achieve “best practices”

Mentoring:

• Mentor entry-level team member if needed
• Manage internal and external employees/contractors

Education:

• Continuously seek knowledge regarding most current statistical methods.
• Prepare presentations for internal and external audiences (presenting at key statistical meetings).

QUALIFICATION:

• M.S. or Ph.D. (or equivalent) in Statistics or Biostatistics is required.
• Minimum 4 years (Ph.D.) or  8 years (M.S.) pharmaceutical industry experience
• Should possess experience interacting with regulatory agencies (e.g. FDA, MHRA or EMEA).
• Experience managing multiple projects/therapeutic areas.
• Experience in managing external vendors (e.g. contractors, CROs).
• Capability in working independently and lead one or multiple clinical studies. 

Knowledge

• Solid background of statistics
• Experience of SAS, R and other statistical programming packages to validate key endpoint analysis.
• Possess extensive knowledge of the Drug Development Process.
• Possess extensive knowledge of regulatory policies and procedures.

Skills & Abilities:

• Ability dealing with ambiguity.
• Ability to handling stress.
• Drive for results.
• Ability to prioritize.
• Ability to establish and maintain effective working relationships with team members, managers, and partners.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Principal#Contract

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Business Development Director to join our internal team in the United Kingdom, preferably in the Greater London/Cambridgeshire area.  You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

As Business Development Director, you will be responsible for lead generation, opportunity assessment, creating new accounts and growing existing accounts. Previous experience working with a global Contract Research Organization and selling full service global CRO services is required.   

Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

• Identify, assess, and pursue new business opportunities.
• Previous experience selling full service CRO services is required.
• Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations.
• Develop a deep appreciation for the client's business challenges and organizational structure and use this insight to develop realistic and actionable account plans.
• Contribute to the ongoing refinement of the company's business development approach, defining client and vertical targets, minimizing the cost of sales, and increasing both efficiencies and closing rates.
• Work to exceed revenue targets that align with the company's growth objectives.

Education, Experience and Skills:

• 6+ years of sales and account management experience
• Established a network of decision-makers in the life-sciences industry.
• Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders.
• Strong negotiation skills with a proven track record of closing complex business deals
• Persuasive and compelling presentation and communication skills, both written and verbal
• Ability to interpret business challenges and present quick and responsive high-level solutions.
• Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle.
• Positive employer and client references
• BA, MBA, or equivalent experience

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Director of Business Development, business development, marketing, contracting, travel, clinical trials, CRO, Clinical Research Organization, clinical development, CRO management, relationship management, clinical research sales, account management

#LI-LG1 #LI-Remote

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

re you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Regulatory Affairs Jr. Specialist Consultant / Especialista Jr. de Asuntos Regulatorios

Location / Ubicación: Ciudad de México, México

Position Summary / Resumen del puesto:

Support the preparation, review and follow-up of regulatory submissions for medical devices, ensuring compliance with applicable regulations before health authorities such as COFEPRIS, enabling timely approvals and maintenance of product registrations.

Apoyar en la preparación, revisión y seguimiento de trámites regulatorios para dispositivos médicos, asegurando el cumplimiento de la normativa aplicable ante la autoridad sanitaria COFEPRIS, facilitando la obtención y mantenimiento de los registros sanitarios.

Key responsabilities / Responsabilidades principales:

• Prepare and compile regulatory documentation for COFEPRIS submissions (registrations, renewals, changes).
• Follow up on submissions with regulatory authority (COFEPRIS).
• Support interpretation of local and international regulations.
• Support coordination of requests and activities with cross-functional teams.
• Maintain updated regulatory files and databases.

• Preparar y compilar documentación regulatoria para sometimientos ante COFEPRIS (registros, renovaciones, modificaciones).
• Dar seguimiento a los trámites ante autoridad regulatoria (COFEPRIS).
• Apoyar en la interpretación de normativas locales e internacionales.
• Apoyar la coordinación de solicitudes y actividades con áreas internas.
• Mantener actualizados archivos regulatorios y bases de datos.

Qualifications / Requisitos:

Bachelor’s degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biomedical Engineering, Biotechnology, or related field.

Licenciatura en Química, QFB, QFI, QBP, Farmacia, Ingeniería Biomédica, Biotecnología o afín.

Experience / Experiencia:

Minimum 1 year of experience in regulatory affairs, quality or medical device industry.

Technical skills / Conocimientos técnicos:

• Mexican medical device regulations (COFEPRIS).
• Medical device classification.
• NOMs and standards aplicable.
• Intermediate-advanced English (technical reading required).
• Intermediate Excel skills (data tracking, pivot tables, basic formulas, reporting).

Core competencies / competencias clave:

• Attention to detail.
• Organizational and documentation skills.
• Effective communication.
• Team collaboration
• Learning Agility.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

JOB DESCRIPTION

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Sr. Regulatory Affairs Specialist Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

The Regulatory Affairs Specialist I is responsible for providing operational and administrative support to Regulatory Affairs activities for the Medical Devices portfolio in Colombia. Under guidance from more senior Regulatory Affairs professionals, this role supports regulatory documentation management, systems updates, and project coordination to ensure compliance with applicable regulations and Clients internal requirements.

Key Responsibilities

• Support collection and tracking of regulatory documentation for INVIMA submissions.
• Perform initial completeness checks of regulatory documentation.
• Maintain organized and audit-ready regulatory files.
• Assist with execution of approved regulatory plans under supervision.

• Update regulatory systems, databases, and trackers.

  • Support coordination of regulatory projects and cross-functional requests.
  • Ensure compliance with company policies and procedures.

  Qualifications

  Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related field.
• Entry-level role; prior internships or exposure to regulated environments is a plus.
• Basic understanding of Colombian medical device regulations (Decree 4725 of 2005).

• Proficiency in Microsoft Office tools.
    Manejo de herramientas Microsoft Office.

  • Strong attention to detail and willingness to learn.
    Alta atención al detalle y disposición para aprender.

  Core Competencies & Behaviors / Competencias y Comportamientos Clave

  • Learning agility and curiosity.
    Agilidad de aprendizaje y curiosidad.
  • Attention to detail.
    Atención al detalle.
  • Accountability for assigned tasks.
    Responsabilidad sobre las tareas asignadas.
  • Collaboration with cross-functional teams.
    Colaboración con equipos multifuncionales.
  • Proactive communication.
    Comunicación proactiva.

  Other Information / Información Adicional

  This role requires responsible handling of confidential and regulated information and is performed under supervision in alignment with established regulatory procedures.

  Este cargo requiere el manejo responsable de información confidencial y regulada y se desempeña bajo supervisión, de acuerdo con los procedimientos regulatorios establecidos.

Key Words: Regulatory Affairs, data analysis, EU MDD, EU MDR

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for an Principal Biostatistician Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Job Summary

We are seeking an experienced Principal Biostatistician to provide statistical leadership for oncology clinical development programs. This role will support Phase I–III clinical trials and contribute to regulatory submissions while collaborating closely with cross-functional teams.

Key Responsibilities

• Provide statistical leadership for oncology clinical trials across multiple phases (Phase I–III).

• Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs).

• Design and review statistical methodologies for efficacy and safety analyses.

• Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards.

• Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs.

• Collaborate with clinical development, data management, programming, regulatory, and medical teams.

• Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA).

• Provide strategic input on study design, endpoint selection, and sample size calculations.

• Mentor junior statisticians and provide technical guidance.

Qualifications

• PhD or MS in Statistics, Biostatistics, or related field.

• 8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics.

• Strong experience in oncology clinical trials.

• Hands-on experience with survival analysis, time-to-event endpoints, and complex oncology study designs.

• Proficiency in SAS and/or R.

• Strong knowledge of CDISC standards (SDTM, ADaM).

• Experience supporting regulatory submissions.

• Excellent communication and leadership skills.

Preferred Qualifications

• Experience with adaptive designs and Bayesian methods.

• Prior experience interacting with regulatory agencies.

• Experience in immuno-oncology or hematology oncology.
  
  

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Principal#Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…

ClinChoice is searching for an Environmental Healthy and Safety (EHS) Specialist to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE), open to either a temporary employee on a 12 month fixed term contract, or a freelancer.  

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Main Job Tasks and Responsibilities:

• Direct contact for all Environmental, Health and Safety related topics within the facility, for running and future operations.
• Ensure proper follow-up of incidents / good saves within the Business Unit including quality of reporting and investigations, including leading or facilitating incident investigations and reporting outcome to management.
• Coach, lead Environmental, Health and Safety Representatives/Ambassadors on the shopfloor.
• Understand Business Unit Environmental, Health and Safety competency gaps and work with Environmental, Health and Safety Standard Owners on closing these gaps.
• Perform Environmental, Health and Safety assessments within Business Unit projects and changes.
• Participate in internal/external audits and inspections (for example ISO 14001/45001, J&J EHS Comprehensive Audits, governmental agencies) and coordinate the Business Unit preparation for these audits.
• Support and conduct Environmental, Health and Safety related risk assessments like facility, ergonomic, chemical and biosafety risk assessments and mitigation plans.
• Collaborate with the Environmental, Health and Safety department, Biosafety Officer and the Operational Standard Owner.
• Present periodically to the Operation Readiness Team and relevant stakeholders.
• Working pro-actively.
• Monitor the Business Unit Environmental, Health and Safety processes and performance by trend analysis of data and define follow-up.
• Develop multi-year Environmental, Health and Safety strategy and plan for the business unit.

Education, Experience and Skills:

• 2-4 years (operations) experience in a biotechnology or biopharmaceutical industry environment.
• Bachelor’s degree in safety (e.g., HVK, industrial hygiene or equivalent education).
• Proactively sees and finds work, knowing and visibly taking ownership of responsibilities.
• Excellent communication skills, written and verbal in English (required) and Dutch (preferred).
• Stimulating open communication when mistakes are made/problems arise.
• Dares to say no, can deal with uncertainties, escalates clearly and timely, can adapt communication style to the situation, can absorb complex information and views self-improvement as a priority and acts as a role model.
• Recognizes, acknowledges, and involves employees with different backgrounds, talents, knowledge, and ideas.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Environmental Health & Safety, EHS, CRO, Contract Research Organisation, Outsourced, Pharmaceutical, Pharma

#LI-LG1 #LI-HYBRID

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…

ClinChoice is searching for a Distribution Material Coordinator to work with one of our partner pharmaceutical companies. This is a full-time (1 FTE), permanent position to be hybrid at our client’s site in Mont Saint Guibert for 2 days per week.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

The Distribution Material Coordinator will ensure that clinical trial materials are delivered to patients on time and in optimal condition worldwide, leveraging a network of third party distribution partners. This role will support the approval of new drugs by ensuring robust documentation and addressing any patient risk. In addition, they will be responsible for the compliant and timely movement of clinical trial materials, from initial reception at the distribution hubs, through transfers to other hubs or depots, and finally to clinical sites. This will include overseeing material management during all hub/depot operations.

Main Job Tasks and Responsibilities:

• Oversee all operations performed by hubs/depots, including reception, shipments, labelling and inventory management, in partnership with Quality, Clinical, and hub/depot teams.
• Collaborate with cross-functional teams to understand delivery schedules and priorities, ensuring timely fulfilment at hubs/depots.
• Monitor SAP/KorberOne delivery lists, resolve shipment issues, and conduct investigations as needed.
• Approve Quality Notification Forms from Collaboration Partners and create internal records per procedural requirements (e.g.: external deviations, CART, distribution complaints, change controls).
• Keep accuracy and consistency across SAP, KorberOne, and IWRS systems, addressing system message or interface issues.
• Participate in the creation, update, and training of clinical trial distribution processes.
• Maintain distribution networks diagrams and P-Info records.
• Push Outbound Deliveries from SAP to KorberOne as required.
• Create purchase orders and review/approve invoices for distribution vendors as required.
• Ensure completion of any pre-shipment paperwork and ensure necessary import requirements are in place prior to shipment execution
• Proactively identify and implement improvements in daily activities to support productivity, efficiency, and risk reduction.
• Make Fit For Use determinations in case of temperature excursions.
• Author deviations and change controls and perform investigations as necessary to address departures from SOPs.
• Participate in the creation and update of clinical trial distribution processes and provide training to clients.
• Support efforts and projects to improve productivity, efficiency, product quality, and risk reduction or linked to distribution process change.
• Ensure material set-up in KorberOne for items not packaged by Product Delivery.
• Participate in visits to hubs/depots and affiliates and support conference calls/meeting as needed
• Participate in projects linked to distribution process changes, including associated change controls.
• Ensure compliance with GMP/GDP and all internal/external regulatory requirements for importation, warehousing, labelling, and distribution activities for all product types.
• Ensure all activities comply with company safety, environmental, and confidentiality requirements.
• Maintain up-to-date individual training plans and follow procedures applicable to the clinical trial business.

Education, Experience and Skills:

• Bachelor degree, preferably in health care or supply chain/logistics field or equivalent work experience.
• Experience in managing inventory/supplies or complex supply chains
• Knowledge of clinical trial distribution, cGMP and experience in a highly regulated environment Customer and process focused
• Knowledge of global import/export requirements

• Clinical research/study expertise
• Prior experience with SAP
• Demonstrated exemplary teamwork/interpersonal skills
• Strong organization and self-management skills
• Ability to use and apply multiple computer applications
• Ability to manage multiple tasks and respond to change
• Effective written and verbal communication skills in multi-cultural settings
• High initiative, flexible and positive attitude
• High degree of accuracy with work and attentive to details
• Ability to proactively identify problems and work toward a solution
• Understands global shipping requirements, including country-specific requirements
• Must speak fluent English
  
  

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Distribution Materials Coordinator, Clinical Trial Materials, Clinical Trial Supply, Clinical Trial Distribution, CRO, Contract Research Organisation, Outsourced, Pharmaceutical, Pharma

#LI-LG1 #LI-Hybrid #Permanent

Job Description

Job Title: Senior Executive / Specialist - Case Processing

Employment Type: Contract

Location: Brazil (Remote)

About ClinChoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

 Primary Responsibilities:

Candidate Profile:

• Bachelor’s or Master’s in Pharmacy / Life Sciences or above and in alignment with project / business team requirements.
• Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream.
• Must have hands on experience with MS office applications (Outlook, Excel, Word, Power Point etc.).
• Must be able to Write and speak Japanese.
• Dynamic working hours.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for an Area/Local Safety Officer Consultant for 12 months Contract with possibility of extension to join one of our clients.

Work from the office in Issy-les-Moulineaux, France. is required a minimum of 2 days/week. The individual can work from home the other days of the week.

The Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Main Job Tasks and Responsibilities:

Safety and PV System Management

• Perform the quality check of the PV cases and ensure that the English translation has been properly performed.
• Keep up to date a local tracker of the individual safety reports.
• Be the subject matter expert at local level on the case management activities.
• Closely follow the respect of the regulatory timelines of the submission of the safety reports to the local health authorities and communicate any potential delay to the appropriate teams.
• Establish and maintain local indicators on the compliance of the safety reports submission.
• Oversee the training of the local employees and the business partners. Maintain KPI and present them during regular team meetings.
• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
• Maintain oversight of proper identification of local literature articles for AE reporting as required.
• Perform reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Client departments as applicable.
• Supporting Area Safety Lead in notifying local health authorities of any safety issues including SSI/ESI and Signals.
• Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements.
• Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.
• Perform other agreed tasks assigned by manager
• Perform document management and archiving as required

Procedural Document

• Ensure current knowledge of all relevant company procedures and training.
• Develop, update, and implement local procedures to ensure compliance with Clients global procedures and national requirements.

Audit & Inspection readiness

Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable

PV contract management

Provide PV clauses to be included within local agreements and contribute to the PSMF with contracts-related information

Business Continuity

Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage)

Education and Experience:

Education: health care science professional or equivalent training

• Significant training in data management with strong IT skills.
• 2-4 years of relevant experience (e.g. case data management, reconciliation manager, vigilance IT project manager…).
• Fluent in English. French as a mother tongue.
• Excellent communication skills and ability to work with cross-functional teams.
• Rigor is a key skill for this mission.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Area Safety Officer, Local Safety Officer, PV, QC, CAPA,QPPV

#LI-PB1

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for an Area/Local Safety Officer Consultant for 12 months Contract with possibility of extension to join one of our clients.

The Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Main Job Tasks and Responsibilities:

Safety and PV System Management

• Perform the quality check of the PV cases and ensure that the English translation has been properly performed.
• Keep up to date a local tracker of the individual safety reports.
• Be the subject matter expert at local level on the case management activities.
• Closely follow the respect of the regulatory timelines of the submission of the safety reports to the local health authorities and communicate any potential delay to the appropriate teams.
• Establish and maintain local indicators on the compliance of the safety reports submission.
• Oversee the training of the local employees and the business partners. Maintain KPI and present them during regular team meetings.
• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
• Maintain oversight of proper identification of local literature articles for AE reporting as required.
• Perform reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Client departments as applicable.
• Supporting Area Safety Lead in notifying local health authorities of any safety issues including SSI/ESI and Signals.
• Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements.
• Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.
• Perform other agreed tasks assigned by manager
• Perform document management and archiving as required

Procedural Document

• Ensure current knowledge of all relevant company procedures and training.
• Develop, update, and implement local procedures to ensure compliance with Clients global procedures and national requirements.

Audit & Inspection readiness

Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable

PV contract management

Provide PV clauses to be included within local agreements and contribute to the PSMF with contracts-related information

Business Continuity

Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage)

Education and Experience:

Education: health care science professional or equivalent training

• Significant training in data management with strong IT skills.
• 2-4 years of relevant experience (e.g. case data management, reconciliation manager, vigilance IT project manager…).
• Fluent in English. French as a mother tongue.
• Excellent communication skills and ability to work with cross-functional teams.
• Rigor is a key skill for this mission.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Area Safety Officer, Local Safety Officer, PV, QC, CAPA,QPPV

#LI-PB1

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...

ClinChoice is currently recruiting for a  Manager, Statistical Programming Consultant to join our client’s team —an exciting opportunity to lead impactful statistical strategy in a dynamic environment.

Role Overview

We are seeking an experienced and motivated Manager, Statistical Programming to lead programming activities within the Biometrics group. This role will oversee clinical programming deliverables, drive quality and compliance, support regulatory submissions, and mentor a team of programmers. The ideal candidate will have strong expertise in SAS (and/or R), deep knowledge of CDISC standards, experience with oncology clinical trials, and excellent leadership skills.

Key Responsibilities:

Leadership & Strategy

• Lead and mentor a team of statistical programmers, fostering development and high performance.

• Oversee internal and vendor/CRO programming deliverables, ensuring timelines and quality expectations are met.

• Establish and maintain programming standards, documentation, and best practices.

• Support planning, resourcing, and prioritization for programming activities across multiple studies.

Programming & Technical Delivery

• Oversee development and validation of SDTM and ADaM datasets according to CDISC standards and oncology study requirements.

• Supervise creation of Tables, Listings, and Figures (TLFs) for clinical study reporting and regulatory submissions.

• Ensure all deliverables are of high quality, reproducible, and aligned with regulatory expectations (e.g., FDA, EMA).

• Support automation and efficiency initiatives using SAS and/or R.

• Perform and review QC checks, resolving programming and data issues.

Cross-Functional Collaboration

• Partner closely with Biostatistics, Clinical Data Management, Medical Writing, and Regulatory teams.

• Participate in study team meetings, contributing programming perspective to clinical and data discussions.

• Support preparation of submission-ready deliverables, including reviewer guides, traceability documents, and regulatory artifacts.

Required Qualifications:

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field.

• 9–11+ years of statistical programming experience in the pharmaceutical/biotech/CRO environment.

• Strong proficiency in SAS programming; experience with R is a plus.

• Expert understanding of CDISC standards (SDTM, ADaM).

• Experience managing or mentoring programming teams.

• Demonstrated experience supporting regulatory submissions.

• Excellent communication skills and ability to work collaboratively across functions.
  
  

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Manager#Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Labeling Artwork Controller - Consultant in Poland for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients.

Role Summary

The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision.

Key Responsibilities:

• Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. 
• Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. 
• Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. 
• Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. 
• Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. 
• Drive process improvements related to artwork development, approval workflows, and digital tools. 
• Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. 
• Maintain artwork issue logs and attend escalation meetings to provide updates. 
• Identify inefficiencies and escalate to Hub Leads when required. 
• Participate in content lock meetings to ensure stakeholder alignment. 
• Manage Veraciti system-related issues and escalate appropriately. 
• Suggest and implement technology solutions for artwork and labeling processes. 
• Create, update, and maintain training documentation for systems and processes. 
• Supervise Artwork Controllers to ensure task completion and provide support during peak periods. 
• Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices. 
• Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment. 
• Track and follow up on action items from cross-functional meetings. 
• Communicate project status, risks, and milestones consistently to stakeholders. 
• Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates. 
• Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives. 
• Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required. 
• Conduct design-to-press color management assessments and feasibility consultations. 
• Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks. 
• Address process and executional quality issues; support system and process improvements. 
• Manage ad-hoc artwork-related requests and cascade process/system communications.

Qualifications & Experience:

• Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field; 
• 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries. 
• Strong knowledge of global regulatory requirements for product labeling and packaging. 
• Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment. 
• Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva). 
• Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro). 
• Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.). 
• Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation. 
• Six Sigma Green Belt certification or equivalent experience in continuous improvement. 
• Excellent communication, problem-solving, and organizational skills. 
• PMP certification or formal project management training is a plus.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Regulatory Affairs, Labeling, Artwork, packaging, consumer products

#LI-PR1 #LI-REMOTE #Manager #Contract

About Clinchoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Job Description

Primary Responsibilities:

• Responsible for the coordination and compilation of the relevant data to complete a PSUR.

• Ensures open communication with the stakeholders (Quality, Medical Operations, Clinical, Regulatory Affairs, Medical Safety, etc.) through the PSUR writing process to ensure adherence to published schedules.

• Communicate concerns/delays with data collection and/or reviews within the PSUR Manager Medical Operations to ensure on time completion of the PSUR reports.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Primary Responsibilities:

• Awareness and understanding of relevant GVP modules.
• Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance.
• Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
• Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc.
• Support triage of cases and determine seriousness and relatedness across products as assigned.
• Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative.
• Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
• Involve in process improvement activities such as implementation of quality control process.
• Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries.
• Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
• Maintain PV expertise and understanding of international safety regulations and guidelines.
• Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.
• Provide timely feedback to case processors on the errors/ discrepancies noted.
• Assist in training/mentoring of other case processing/medical review personnel as necessitated.
• Adapt to different client case processing conventions and multi-task as per business needs.
• Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.
• Participate in organizational activities to meet objectives suitable for the role/area of expertise.

Candidate Profile:

• Medical Physician with at least 2 years of experience as Medical Reviewer for ICSRs.
• Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
• Training and mentoring skills (GVP concepts & medical aspects such as disease condition, product portfolio etc).
• Must have hands-on experience with MS Office applications (Outlook, Excel, Word, Power Point etc).

About Clinchoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Job Description

Primary Responsibilities:

• Responsible for the coordination and compilation of the relevant data to complete a PSUR.

• Ensures open communication with the stakeholders (Quality, Medical Operations, Clinical, Regulatory Affairs, Medical Safety, etc.) through the PSUR writing process to ensure adherence to published schedules.

• Communicate concerns/delays with data collection and/or reviews within the PSUR Manager Medical Operations to ensure on time completion of the PSUR reports.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are always interested in hearing from skilled individuals who would be interested in joining our company. By sending your CV to us, we will notify you when a suitable position becomes available matching your experience and skillset. 

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Labeling Artwork Controller - Consultant in Czech Republic for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients.

Role Summary

The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision.

Key Responsibilities:

• Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. 
• Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. 
• Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. 
• Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. 
• Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. 
• Drive process improvements related to artwork development, approval workflows, and digital tools. 
• Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. 
• Maintain artwork issue logs and attend escalation meetings to provide updates. 
• Identify inefficiencies and escalate to Hub Leads when required. 
• Participate in content lock meetings to ensure stakeholder alignment. 
• Manage Veraciti system-related issues and escalate appropriately. 
• Suggest and implement technology solutions for artwork and labeling processes. 
• Create, update, and maintain training documentation for systems and processes. 
• Supervise Artwork Controllers to ensure task completion and provide support during peak periods. 
• Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices. 
• Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment. 
• Track and follow up on action items from cross-functional meetings. 
• Communicate project status, risks, and milestones consistently to stakeholders. 
• Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates. 
• Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives. 
• Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required. 
• Conduct design-to-press color management assessments and feasibility consultations. 
• Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks. 
• Address process and executional quality issues; support system and process improvements. 
• Manage ad-hoc artwork-related requests and cascade process/system communications.

Qualifications & Experience:

• Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field; 
• 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries. 
• Strong knowledge of global regulatory requirements for product labeling and packaging. 
• Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment. 
• Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva). 
• Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro). 
• Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.). 
• Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation. 
• Six Sigma Green Belt certification or equivalent experience in continuous improvement. 
• Excellent communication, problem-solving, and organizational skills. 
• PMP certification or formal project management training is a plus.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Regulatory Affairs, Labeling, Artwork, packaging, consumer products

#LI-PR1 #LI-REMOTE #Manager #Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Labeling Artwork Controller - Consultant in Italy for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients.

Role Summary

The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision.

Key Responsibilities:

• Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. 
• Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. 
• Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. 
• Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. 
• Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. 
• Drive process improvements related to artwork development, approval workflows, and digital tools. 
• Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. 
• Maintain artwork issue logs and attend escalation meetings to provide updates. 
• Identify inefficiencies and escalate to Hub Leads when required. 
• Participate in content lock meetings to ensure stakeholder alignment. 
• Manage Veraciti system-related issues and escalate appropriately. 
• Suggest and implement technology solutions for artwork and labeling processes. 
• Create, update, and maintain training documentation for systems and processes. 
• Supervise Artwork Controllers to ensure task completion and provide support during peak periods. 
• Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices. 
• Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment. 
• Track and follow up on action items from cross-functional meetings. 
• Communicate project status, risks, and milestones consistently to stakeholders. 
• Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates. 
• Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives. 
• Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required. 
• Conduct design-to-press color management assessments and feasibility consultations. 
• Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks. 
• Address process and executional quality issues; support system and process improvements. 
• Manage ad-hoc artwork-related requests and cascade process/system communications.

Qualifications & Experience:

• Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field; 
• 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries. 
• Strong knowledge of global regulatory requirements for product labeling and packaging. 
• Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment. 
• Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva). 
• Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro). 
• Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.). 
• Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation. 
• Six Sigma Green Belt certification or equivalent experience in continuous improvement. 
• Excellent communication, problem-solving, and organizational skills. 
• PMP certification or formal project management training is a plus.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Regulatory Affairs, Labeling, Artwork, packaging, consumer products

#LI-PR1 #LI-REMOTE #Manager #Contract

In-charge in handling Accounts Payable from processing PO in the ERP systems up to payment processing. Also in charge for PEZA Farm-in and Farm and other PEZA reports.  Employees SSS sickness and maternity notification and reimbursement and PCF.

• AP
  • Create PO and email to Admin/IT for issuance to vendor
  • Process payment
  • Preparation of CWT
  • Filing of CV and AP documents
  • Monitoring of checks on hand and advice vendor for availability of their checks
• Petty Cash Fund
  • PCF replenishment summary and accounting journal
• PEZA
  • Farm – In and Farm Out
  • Weekly reports to PEZA on covid 19 and WFH
• SSS Online Notification and Payment Processing
  • Online submission
  • Reimbursement
  • Monitoring
• General Accounting
  • Accrual of expenses
  • Preparation of FS schedules
  • Compliance Monitoring

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Data Integrity Specialist, Quality Assurance Computer Systems Validation (CSV) to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE) temporary employment position to the end of 2026 initially.

The Data Integrity Specialist will focus on Innovative Medicine Supply Chain systems, primarily from our client in Beerse. Hybrid working with 2 days working from home per week is permitted.   

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Main Job Tasks and Responsibilities:

• Cooperate with multifunctional teams to assess local systems and equipment.
• Define risks and vulnerabilities for the local systems and equipment.
• Provide Data Integrity guidance and support towards local Subject Matter Experts.
• Define remediation activities and create Data Integrity plans.
• Act as local Process Owner for Data Integrity.
• Support the Small Molecules Data Integrity Community of Practice.
• Organize and lead sessions with Data Integrity representatives of multiple sites.
• Assist site Subject Matter Experts with the assessment process of all site specific systems and equipment.
• Assist Site Subject Matter Experts with Data Flow Mapping and Risk Assessments.
• Organize, manage and perform SM Platform based Data Flow Mapping and Risk Assessments.
• Maintain a current knowledge of international laws, guidelines and new evolutions related to Computer System Validation through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve Computer System Validation at sponsor.
• Prepare for audits and inspections by regulatory agencies, customers and internal compliance team.
• Be an Subject Matter Expert for Data Integrity matters during audits and inspections.
• Cooperate with engineering, IT and other teams for the Data Integrity compliance during introduction of new systems, equipment and processes.
• Give advice and support for the preparation of Computer System Validation related activities and guard the cGMP aspects in new projects. Be a member of multi-functional teams to realize cross-departmental objectives.

Education, Experience and Skills:

·        Master scientific degree or equivalent experience.

·        3 years’ experience in the pharmaceutical industry.

·        Knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; Eudralex 4, EU Directive 2003/94/EC, EU Directive 2017/1572 and annex 11; GAMP, Data Integrity Guidelines).

·        Strong ownership and Quality mindset. You are able to deliver on commitment timelines.

·        Ability to make risk-based decisions. Understands the business implications regarding quality positions and decisions.

·        Experience with Data Integrity remediation activities.

·        Experience with Computerized System Validation.

·        Fluent in verbal and written communication in English and Dutch and are able to connect with diverse partners.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Data Integrity Specialist, Computer Systems Validation, DIS, CSV, Quality Assurance, Temporary

#LI-LG1 #LI-Hybrid

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a CAR-T Quality Assurance Engineer to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE) temporary employment position to the end of 2026 initially.

The Engineer will be responsible for the review and approval of qualification and requalification activities, related to Facilities and Utilities and Process Equipment at our client’s facility in Ghent.  

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Main Job Tasks and Responsibilities:

• Work closely with the Make Asset Management and Engineering & Property Services department to guard the qualification status of critical production assets by ensuring that all system critical aspects related to facilities and utilities, product and process requirements are identified; qualified and controlled by a mitigation plan and ensure that deviations related to equipment issues with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventative actions are defined and implemented.
• Work closely together with the manufacturing department to approve new change controls and to ensure that deviations with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented.
• Build strong connections with different quality organizations.
• Manage the compliance status of critical production assets by means of review and approval of procedures e.g. calibration rationales, calibration master forms and completed calibration records, master data set-up, maintenance plans and follow up daily operations activities by review and approval of data integrity deliverables such as system audit trail and user access reviews.
• Participate in the preparation for regulatory and customer inspections and act as a spokesperson for Quality Assurance qualification.
• Approve qualification documents (change controls, master documents, protocols, reports, rationales, SOP’s, URS, IA, QSR, etc.) including discrepancies/events/non-conforming situations and related corrective actions (correction, CPA) occurring during execution of qualification activities.
• Participate in system and process improvement / optimization projects and assure quality and compliance aspects and maintain a current knowledge of international regulations, guidelines and industry practices and become the QA process expert.

Education, Experience and Skills:

·        Master’s degree in engineering with chemistry or analytical background or in pharmaceutical sciences

·        Awareness of quality; have knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell therapy products and you see it as a challenge to defend our strategy and documents towards health authority inspections.

·        Affinity with computerized systems, System parameter configurations and data management in critical production assets.

·        Ability to show and apply strong communication skills and are known as a great teammate who can work cross departmental in a continuous changing environment.

·        Thorough knowledge of Dutch and English, both orally and in writing

·        Strong analytical thinking, risk assessment, and communication skills

·        Collaboration and teaming skills

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Assurance Engineer, CAR-T, QA Officer, Quality Officer, Quality Assurance Specialist, QA Specialist, Temporary#

#LI-LG1 

ClinChoice is hiring a Financial Analyst to join our Finance Shared Service Center in Philippines. This position will play an integral role in supporting the global forecasting, planning, and management reporting process. This candidate will report to Director, FP&A and will also partner with teams across finance and other departments.

Responsibilities:

• Assist with compilation, review, and presentation of the company’s budgeting and forecast submissions.
• Assist with the preparation and delivery of monthly management reports which identify, track, and analyze key metrics.
• Proactively understand and provide interpretation for periodic variances of actual financial results to previous forecasts, budget, and prior periods.
• Partner with other finance team members to support various business leaders to better understand the company’s financial performance.
• Collaborate with other FP&A team members to drive management reporting accuracy and timeliness.

Qualifications:

• Bachelor’s degree in accounting, finance, or related field
• Solid understanding of accounting principles and financial statements
• Intermediate to advanced Microsoft Excel and PowerPoint skills
• Flexibility in working hours to accommodate the schedules of team members in different time zones.
• Professional verbal and written proficiency in English required.
• Strong analytical, intellectual curiosity and integrity, motivated to solve problems.

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as an Associate, Regulatory Affairs on a permanent basis. 

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities: 

• Support with new application for marketing authorization/renewal/variation of medicinal products, medical devices, cosmetics, food supplements for regulatory submission and follow-up closely on queries from HA through to approval
• Publishing and submission of products registration applications
• Coordination of activities ensuring product registration information is accurate and current
• Support compilation, tracking, indexing and archival of regulatory information
• Specifying storage, labelling and packaging requirements for regulated products
• Creation, update, review and quality check of product labels

Education and Experience:

• Bachelor’s Degree in Life Science (Chemistry, Biology, Biomedical Engineering)
• Experience in the related field is a plus
• Fluency in English
• Ability to work under pressure to meet the deadlines
• Ability to get a challenge and perform excellent teamwork

Our Benefits: 

• Flexible Working Hours
• Full performance and development process with end of year reviews
• Team events and end of year party
• Employee satisfaction survey - your feedback is important for continuous improvement
• Health Insurance

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. 

Who will you be working for?

About ClinChoice  
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Job Title: Physician Sub-Investigator Consultant

Location: Location: 3340 Enterprise Way, Miramar, FL, 33025 (Temp to permanent.)

Assignment length: Per-diem, ongoing assignment year over year

ClinChoice is searching for Physician Sub-Investigator Consultant 12 months Contract with possibility of extension.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Shift Schedule:

Variable, including weekends and evenings as-needed, typically 8hr duration, always coordinated before shift assignment. The hours will be variable depending on projects at the clinic, and may include days for what would typically be screening assessments or admission assessments, or evenings/weekends for study-related procedures such as dosings, ECG review and interpretation, lab review and interpretation.

Position Summary

Core Essential Skills:
a) ABIM board certified (and verified) in internal medicine (and may be subspecialized as well).
b) Experience in clinical medicine which may include hospital-based or clinic-based practices, for at least one year after their terminal training.
c) Clean DEA registration and unrestricted license to practice medicine in Florida.
d) MD with board certification in internal medicine, active FL medical license, unrestricted license

Screenings:
1. Basic Background check
2. 11 Panel Drug + Fentanyl

Description:
• The duties may include screening procedures such as routine physical examinations of healthy volunteers, ECG interpretation, review of labs, eligibility assessment for prospective study participants, management of adverse events, on-site supervision of investigational product dosing, and related duties.
• Delegates study responsibilities as appropriate to trained study staff
• Possesses a working knowledge of GCP/ICH guidelines, Clinic SOPs, QA/QC procedures, and Investigator 1572 Form
• Reviews Investigator’s Brochure prior to performing any study procedures
• Performs all study responsibilities in compliance with the IRB approved protocol
• Reviews screening documentation and approves subject for admission to study
• Reviews admission documentation and approves subject for randomization
• Interprets ECGs within agreed Sponsor timeline
• Documents all findings in subject specific source documents
• Provides ongoing assessment of the study subject/patient to identify Adverse Events
• Ensures proper documentation and reporting of all Adverse Events and Serious Adverse Events
• Reviews and evaluates all study data and comments to the clinical significance of any out-of-range results
• Performs physical examinations as part of screening evaluation and active study conduct
• Provides medical management of adverse events as appropriate
• Completes all study documentation in accordance with the study specific requirements
• Communicated with Sponsors and auditors as requested
• Participates in on-call activities as required to ensure adequate medical coverage
• Monitors safety and well-being of study participants at all times
• Provides coverage for the Clinic Principal Investigator
•They should be able to work and thrive in a team-based environment.

#LI-PB1 #LI-On-Site

Key words: Physician, Investigator, Clinic Principal Investigator

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...

ClinChoice is searching for a Principal Statistical Programmer Consultant to join one of our clients. 

The Principal Statistical Programmer will serve as a senior technical expert responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors. This role requires advanced expertise in SAS, familiarity with R, deep knowledge of CDISC standards, and strong experience working on oncology studies and regulatory submissions.

Key Responsibilities

Technical Leadership

• Lead programming activities for oncology clinical trials across multiple studies.

• Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines.

• Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions.

• Provide SAS programming expertise to support complex data derivations and analyses.

• Review and ensure traceability, consistency, and quality of all programming deliverables.

Project & Study Management

• Act as programming lead for assigned studies, managing timelines and deliverables.

• Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs.

• Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards.

• Support integrated analyses including ISS/ISE.

Regulatory & Submission Support

• Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.

• Ensure all programming meets regulatory requirements (FDA, EMA, PMDA).

• Contribute to responses for regulatory queries and data requests.

Required Qualifications

• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.

• 8–12+ years of statistical programming experience in pharma/biotech or CRO.

• Expert-level proficiency in SAS.

• Strong understanding of CDISC SDTM and ADaM standards.

• Significant experience supporting oncology clinical trials (hematologic or solid tumors).

• Experience supporting regulatory submissions and preparing submission-ready outputs.

• Excellent communication skills and ability to collaborate cross-functionally.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-DNP

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Labeling Artwork Controller Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Job Description

Artwork Controller

Role Summary

The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision.

Key Responsibilities:

• Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components.
• Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies.
• Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies.
• Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects.
• Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards.
• Drive process improvements related to artwork development, approval workflows, and digital tools.
• Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed.
• Maintain artwork issue logs and attend escalation meetings to provide updates.
• Identify inefficiencies and escalate to Hub Leads when required.
• Participate in content lock meetings to ensure stakeholder alignment.
• Manage Veraciti system-related issues and escalate appropriately.
• Suggest and implement technology solutions for artwork and labeling processes.
• Create, update, and maintain training documentation for systems and processes.
• Supervise Artwork Controllers to ensure task completion and provide support during peak periods.
• Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices.
• Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment.
• Track and follow up on action items from cross-functional meetings.
• Communicate project status, risks, and milestones consistently to stakeholders.
• Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates.
• Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives.
• Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required.
• Conduct design-to-press color management assessments and feasibility consultations.
• Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks.
• Address process and executional quality issues; support system and process improvements.
• Manage ad-hoc artwork-related requests and cascade process/system communications.

Qualifications & Experience:

• Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field;
• 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries.
• Strong knowledge of global regulatory requirements for product labeling and packaging.
• Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment.
• Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva).
• Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro).
• Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.).
• Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation.
• Six Sigma Green Belt certification or equivalent experience in continuous improvement.
• Excellent communication, problem-solving, and organizational skills.
• PMP certification or formal project management training is a plus.

Key Words: Regulatory Affairs, Artwork, Labeling design, proofreading

#LI-PB1 #LI-REMOTE

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Labeling Artwork Controller - Consultant in High Wycombe, UK for 12 months Contract with possibility of extension to join one of our consumer product clients.

Role Summary

The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision.

Key Responsibilities:

• Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. 
• Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. 
• Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. 
• Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. 
• Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. 
• Drive process improvements related to artwork development, approval workflows, and digital tools. 
• Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. 
• Maintain artwork issue logs and attend escalation meetings to provide updates. 
• Identify inefficiencies and escalate to Hub Leads when required. 
• Participate in content lock meetings to ensure stakeholder alignment. 
• Manage Veraciti system-related issues and escalate appropriately. 
• Suggest and implement technology solutions for artwork and labeling processes. 
• Create, update, and maintain training documentation for systems and processes. 
• Supervise Artwork Controllers to ensure task completion and provide support during peak periods. 
• Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices. 
• Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment. 
• Track and follow up on action items from cross-functional meetings. 
• Communicate project status, risks, and milestones consistently to stakeholders. 
• Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates. 
• Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives. 
• Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required. 
• Conduct design-to-press color management assessments and feasibility consultations. 
• Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks. 
• Address process and executional quality issues; support system and process improvements. 
• Manage ad-hoc artwork-related requests and cascade process/system communications.

Qualifications & Experience:

• Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field; 
• 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries. 
• Strong knowledge of global regulatory requirements for product labeling and packaging. 
• Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment. 
• Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva). 
• Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro). 
• Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.). 
• Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation. 
• Six Sigma Green Belt certification or equivalent experience in continuous improvement. 
• Excellent communication, problem-solving, and organizational skills. 
• PMP certification or formal project management training is a plus.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Regulatory Affairs, Labeling, Artwork, packaging, consumer products

#LI-PR1 #LI-HYBRID #Manager #Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Quality Assurance Analyst, Qualification Facility & Utility to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Geel office, until 31 December 2026.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

In this role you will support the QA Engineering department in assuring that all Qualification related regulatory and procedural requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for Geel Facility and Utility systems.

Main Job Tasks and Responsibilities:

• Review and approve qualification documents & quality records such as SOPs, user requirements, impact/risks analysis’s, Test Plans, test scripts, change controls, CAPA’s etc. in order to maintain compliance to regulations, guidelines, and Company policies and standards.
• Be part of engineering teams and interact with other groups for the introduction of new/upgraded systems and processes. To give advice and support for the preparation of qualification related activities and guard the cGMP aspects.
• Address and follow-up of deviations occurred during execution of qualification activities.
• Communicate status (quality & compliance, planning) towards Company QA Qualification team members.

Education and Experience:

• University/Bachelor’s Degree or Equivalent.
• Experience in chemical and/or pharmaceutical industry with respect to qualification of equipment.
• Knowledge of cGMP regulations and guidelines.
• Capacity to ‘translate’ technical information into information that can be understood at every level of the organization.
• Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.
• Ability to multi-task and work on a variety of projects at one time.
• Ability to work independently and work in cross-functional team environment.
• Good communication skills.
• Fluent in English and Dutch (spoken and written).
• Facility and Utility systems used within pharmaceutical or chemical industry.
• Problem report, change request systems. (f.e. Trackwise, Comet).
• Document Management systems (f.e. TruVault).
• Test tools (f.e. Kneat).

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Assurance Analyst, Qualification Facility & Utility, Quality Management System, CAPA, GMP, Regulatory Compliance, Technical Documentation, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #LI-ONSITE #TEMPORARY

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Quality Assurance Qualification Contractor to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Geel office, until 31 December 2026.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

In this role you will support the QA Engineering department in assuring that all Qualification related regulatory and procedural requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for Geel manufacturing systems.

Main Job Tasks and Responsibilities:

• Review and approve qualification documents & quality records such as SOPs, user requirements, impact/risks analysis’s, Test Plans, test scripts, change controls, CAPA’s etc. in order to maintain compliance to regulations, guidelines, and Company policies and standards.
• Be part of engineering teams and interact with other groups for the introduction of new/upgraded systems and processes. To give advice and support for the preparation of qualification related activities and guard the cGMP aspects.
• Address and follow-up of deviations occurred during execution of qualification activities.
• Communicate status (quality & compliance, planning) towards Company QA Qualification team members.

Education and Experience:

• University/Bachelor’s Degree or Equivalent.
• Experience in chemical and/or pharmaceutical industry with respect to qualification of equipment.
• Knowledge of cGMP regulations and guidelines.
• Capacity to ‘translate’ technical information into information that can be understood at every level of the organization.
• Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.
• Ability to multi-task and work on a variety of projects at one time.
• Ability to work independently and work in cross-functional team environment.
• Good communication skills.
• Fluent in English and Dutch (spoken and written).
• Manufacturing systems used within pharmaceutical or chemical industry.
• Problem report, change request systems. (f.e. Trackwise, Comet).
• Document Management systems (f.e. TruVault).
• Test tools (f.e. Kneat).

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Assurance Qualification Contractor, Quality Management System, CAPA, GMP, Regulatory Compliance, Technical Documentation, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #LI-ONSITE #TEMPORARY