Company Background

Our client is a leading global provider of advanced analytics, technology solutions, and clinical research services for the life sciences industry. The company combines large-scale healthcare data with AI-powered analytics to accelerate drug development, clinical trials, and commercialization for pharmaceutical and biotech companies. It was named to Fortune’s World’s Most Admired Companies list in 2026.

Project Description

Our client is looking for a Senior Full-stack Engineer to support full-stack development initiatives in the healthcare advertising domain. The specialist will work in a SCRUM-based team and contribute to technical decisions, solution design, development, documentation, API integrations, and stakeholder communication.

Technologies

• C#
• .NET
• Vue.js (or other frontend framework)
• API
• SQL
• AWS

What You'll Do

• Contribute to full-stack development using .NET, SQL, AWS, and Vue.js (or any other frontend framework);
• Drive technical decisions and participate in solution design and project documentation;
• Develop and support API integrations with other services;
• Work on application performance optimizations;
• Review technical solutions and provide technical guidance to the team when needed;
• Communicate with client stakeholders and take ownership of assigned deliverables;

Job Requirements

• 8+ years of experience as a Full-stack Engineer;
• Strong backend experience with C# / .NET;
• Strong experience with Vue.js or another modern front-end framework;
• Experience with SQL databases;
• Experience with API development and integrations;
• Experience with AWS;
• Ability to participate in technical discussions, documentation, and client communication;
• Strong ownership and responsibility for deliverables;
• Great verbal and written communication skills;
• English level: B2 or higher; 

What Do We Offer

The global benefits package includes:

• Technical and non-technical training for professional and personal growth;
• Internal conferences and meetups to learn from industry experts;
• Support and mentorship from an experienced employee to help you professional grow and development;
• Health insurance;
• English courses;
• Sports activities to promote a healthy lifestyle;
• Flexible work options, including remote and hybrid opportunities;
• Referral program for bringing in new talent;
• Work anniversary program and additional vacation days.

Legend Biotech is seeking a Leadership Excellence & Acceleration Pathway Associate as part of the Commercial team based Remotely (South Central Region).

Role Overview

The Leadership Excellence & Acceleration Pathway (LEAP) Associate is a selective, high-impact role designed to accelerate the development of the next generation of commercial leaders at Legend Biotech.

LEAP Associates participate in a structured, end-to-end commercial development experience spanning key commercial functions, paired with real accountability, senior leader exposure, and hands-on ownership of meaningful business work. The program is intentionally designed for high-potential professionals who have demonstrated strong execution, leadership maturity, and a desire to grow into broader commercial leadership roles within biotech.

Unlike traditional entry-level or functional roles, LEAP Associates are positioned as enterprise-minded contributors, expected to think strategically, execute rigorously, operate across functions, and continuously elevate how work gets done, including through modern, AI-enabled ways of working.

Upon successful completion, participants are expected to be ready for expanded-scope commercial roles within the organization.

Preferred Locations/Territories:

• • Albuquerque, NM
  • Houston, TX
  • New Orleans, LA

Program Overview

• 18-24 month structured rotational development program.
• Exposure across core commercial functions such as: Field Sales, Marketing, Market Access.
• Embedded learning curriculum focused on:
  • End-to-end commercial strategy and execution.
  • Cross-functional leadership and influence.
  • Decision-making in complex, data-rich environments.
  • Responsible and practical application of AI in commercial work.
  • Ongoing mentorship, performance feedback, and senior leader engagement.

(Specific rotation assignments and sequencing will be determined based on business priorities and developmental needs.)

Key Responsibilities

• Across the program, LEAP Associates will be expected to:
• Drive execution by contributing to priority commercial initiatives and business-critical projects across functions.
• Translate strategy into action, supporting planning, analysis, and execution efforts that directly impact commercial performance.
• Operate cross-functionally, effectively partnering with Sales, Marketing, Market Access, Commercial Operations, and other stakeholders.
• Bring structure and insight to ambiguity, using data, judgment, and stakeholder input to support sound decision-making.
• Demonstrate ownership and accountability for outcomes—not just deliverables.
• Build influence without authority, navigating complex stakeholder environments with professionalism and credibility.
• Continuously elevate ways of working, including identifying opportunities to improve efficiency, rigor, and scalability.

AI-Enabled Ways of Working

A core expectation of the LEAP program is the development of applied AI fluency. LEAP Associates will:

• Leverage approved AI tools to support:
  • Commercial analysis and insight generation.
  • Planning and scenario evaluation.
  • Content development and communication.
  • Workflow efficiency and execution effectiveness.
• Apply AI responsibly and in alignment with company governance and standards.
• Identify and share best practices for integrating AI into everyday commercial work.
• Help translate AI-enabled capabilities to teams and stakeholders, supporting broader adoption and impact.

AI is treated as a practical leadership capability, not a theoretical skillset.

Requirements

Required:

• Bachelor’s degree.
• 5–7 years of professional experience.
• Demonstrated track record of execution, ownership, and results delivery.
• Strong analytical, communication, and problem-solving skills.
• Interest in biotech/pharma and commercial leadership pathways.

Preferred:

• Experience in disciplined, performance-driven environments (e.g., military service or similarly structured settings).
• Exposure to commercial, operational, analytical, or customer-facing roles.
• Experience using data, analytics, digital tools, or AI-enabled solutions to support decision-making.
• Comfort working in complex, matrixed organizations.

Developmental Opportunities:

• Exposure to senior leadership.
• Cross-functional rotations.
• Mentorship and coaching.
• Potential placement into full-time commercial roles upon program completion.

#Li-JK1

#Li-Remote

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Start Up Lead (SUL) in Mexico!

The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:

• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:

• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

Preferred:

• Advanced degree in life sciences or related field

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.
• Excellent organizational skills.
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located.
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.
• Must demonstrate excellent computer skills.
• Excellent time management and prioritization skills to ensure deadlines are met.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Occasional travel may be required.

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Start Up Lead (SUL) in Mexico!

The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:

• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:

• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

Preferred:

• Advanced degree in life sciences or related field

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.
• Excellent organizational skills.
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located.
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.
• Must demonstrate excellent computer skills.
• Excellent time management and prioritization skills to ensure deadlines are met.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Occasional travel may be required.

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Regulatory and Start Up Specialist (Senior RSS) in Mexico!

As the Senior RSS on our team, you are a seasoned, experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the Senior RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and providing support to the Site Contract Management group in budget and contract negotiation.

The Senior RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities, trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities and ensure compliance with local and international clinical trials regulations and guidelines.

Essential functions of the job include but are not limited to:

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities (CA), Ethics Committee (EC) and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP
• Interaction with CA/EC for study purposes and handling responses to the CA/EC
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration
• Prepare, review and manage collection of essential documents required for site activation/IMP release
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within Precision for Medicine to ensure the conduct of Clinical Trials according to international and local/national applicable regulations
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study
• May support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors
• May support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries
• May mentor staff on local study start-up regulations, submissions, and internal procedures
• May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required
• Performs other duties as assigned by management

Qualifications

Minimum Required:

• Bachelors’ degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience
• 3.5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Other Required:

• Excellent communication and organizational skills are essential
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
• Fluency in English and for non-English speaking countries the local language of country where position based
• Ability to prioritize workload to meet deadlines

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country
• Experience using milestone tracking tools/systems
• Can assist junior SU specialists in problem resolution
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
• Excellent organizational skills
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace
• Must demonstrate excellent computer skills
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Flexible attitude with respect to work assignments and new learning
• Occasional travel may be required

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Feasibility Associate to join our team at Precision for Medicine!

As part of this team, you'll support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Senior Feasibility Associate supports pre-award feasibility projects and support business development and operational strategy teams by conducting global feasibility analyses. The Senior Feasibility Associate supports feasibility projects for newly awarded and/or ongoing clinical trials and supports start-up and clinical teams with site identification. In addition, Senior Feasibility Associate may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

Essential functions of the job include but are not limited to:

• Support pre-award feasibility projects
• Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis.
• Review clinical protocols, study assumptions, client information and study plans for US and global trials.
• Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale.
• Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
• Undertake feasibility site outreach for pre award opportunities.
• Participate and/or contribute to BDM and client calls.
• Apply process, templates and delivery standards for feasibility pre-award.
• Provide support to post-award feasibility projects
• Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements.
• Provide management of feasibility project team pertaining to the conduct of the feasibility:
• Provide training and training materials.
• Ensure accuracy and quality of the survey data.
• Oversee and /or conduct the site outreach process.
• Participate and or/contribute to feasibility KOM and feasibility progress meetings with the sponsor.
• Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery.
• Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)
• Apply process, tracking, templates, data structure delivery standards for post award and stand-alone feasibility.
• Work closely with the Precision study teams to assess required input from the feasibility team, and agree on delivery plan, including roles and responsibilities, for feasibility pre- and post-award.
• Follow post and pre award feasibility process, SOPs templates and tools.

Qualifications:
Minimum required:

• Bachelor’s degree in a life sciences discipline
• A minimum of 5 years of related experience
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative.

Other Required:

• Relevant experience in the required activities for the role including feasibility analysis, site identification.
• Domestic and international travel including overnight stays.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred:

• Postgraduate degree preferred.

Skills:

• Strong management and organizational skills
• Excellent oral and written communication skills in English
• Strong rationale and analytical thinking
• Strong IT platform and data analysis skills
• Strong presentation abilities
• Advanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms

Competencies:

• Strong sense of ownership and pride in quality of outputs
• Good to strong attention to detail
• Team player
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Demonstrates knowledge of ICH-GCP

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Feasibility Associate to join our team at Precision for Medicine!

As part of this team, you'll support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Senior Feasibility Associate supports pre-award feasibility projects and support business development and operational strategy teams by conducting global feasibility analyses. The Senior Feasibility Associate supports feasibility projects for newly awarded and/or ongoing clinical trials and supports start-up and clinical teams with site identification. In addition, Senior Feasibility Associate may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

Essential functions of the job include but are not limited to:

• Support pre-award feasibility projects
• Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis.
• Review clinical protocols, study assumptions, client information and study plans for US and global trials.
• Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale.
• Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
• Undertake feasibility site outreach for pre award opportunities.
• Participate and/or contribute to BDM and client calls.
• Apply process, templates and delivery standards for feasibility pre-award.
• Provide support to post-award feasibility projects
• Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements.
• Provide management of feasibility project team pertaining to the conduct of the feasibility:
• Provide training and training materials.
• Ensure accuracy and quality of the survey data.
• Oversee and /or conduct the site outreach process.
• Participate and or/contribute to feasibility KOM and feasibility progress meetings with the sponsor.
• Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery.
• Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)
• Apply process, tracking, templates, data structure delivery standards for post award and stand-alone feasibility.
• Work closely with the Precision study teams to assess required input from the feasibility team, and agree on delivery plan, including roles and responsibilities, for feasibility pre- and post-award.
• Follow post and pre award feasibility process, SOPs templates and tools.

Qualifications:
Minimum required:

• Bachelor’s degree in a life sciences discipline
• A minimum of 5 years of related experience
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative.

Other Required:

• Relevant experience in the required activities for the role including feasibility analysis, site identification.
• Domestic and international travel including overnight stays.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred:

• Postgraduate degree preferred.

Skills:

• Strong management and organizational skills
• Excellent oral and written communication skills in English
• Strong rationale and analytical thinking
• Strong IT platform and data analysis skills
• Strong presentation abilitiesAdvanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms

Competencies:

• Strong sense of ownership and pride in quality of outputs
• Good to strong attention to detail
• Team player
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Demonstrates knowledge of ICH-GCP

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Regulatory and Start Up Specialist (Senior RSS) in Mexico!

As the Senior RSS on our team, you are a seasoned, experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the Senior RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and providing support to the Site Contract Management group in budget and contract negotiation.

The Senior RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities, trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities and ensure compliance with local and international clinical trials regulations and guidelines.

Essential functions of the job include but are not limited to:

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities (CA), Ethics Committee (EC) and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP
• Interaction with CA/EC for study purposes and handling responses to the CA/EC
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration
• Prepare, review and manage collection of essential documents required for site activation/IMP release
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within Precision for Medicine to ensure the conduct of Clinical Trials according to international and local/national applicable regulations
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study
• May support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors
• May support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries
• May mentor staff on local study start-up regulations, submissions, and internal procedures
• May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required
• Performs other duties as assigned by management

Qualifications

Minimum Required:

• Bachelors’ degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience
• 3.5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Other Required:

• Excellent communication and organizational skills are essential
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
• Fluency in English and for non-English speaking countries the local language of country where position based
• Ability to prioritize workload to meet deadlines

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country
• Experience using milestone tracking tools/systems
• Can assist junior SU specialists in problem resolution
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
• Excellent organizational skills
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace
• Must demonstrate excellent computer skills
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Flexible attitude with respect to work assignments and new learning
• Occasional travel may be required

#LI-AG2 #LI-REMOTE