Position Summary:

The Senior Clinical Data Engineer leads the strategic development and optimization of clinical data systems to support regulatory compliance, advanced analytics, and operational excellence across global trials. This role drives enterprise-level data standardization initiatives,  and architects scalable validation frameworks to proactively address systemic data issues. With deep expertise in Python, R, SQL, and SAS, the engineer builds and maintains modular codebases, sets coding standards, and mentors junior engineers. The role also oversees regulatory alignment with GCP and FDA 21 CFR Part 11, establishing robust documentation and audit trail protocols. Through dynamic dashboards and analytics tools, the engineer delivers actionable insights into trial performance and data quality. As a strategic liaison across Biostatistics, Clinical Operations, and Regulatory Affairs, the engineer translates clinical requirements into scalable technical solutions and leads the design of secure, high-performance databases and ETL pipelines integrating data from diverse clinical systems.

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

Data Standardization & Mapping -  Spearhead the development of enterprise-level data mapping strategies that transform raw clinical data into standardized formats for high-impact analytics. Lead the adoption and governance of data standards across programs to ensure regulatory alignment and consistency. 

Data Quality Assurance - Design and implement robust, scalable validation frameworks that proactively detect and resolve systemic data issues. Serve as a strategic partner to Clinical Data Managers and cross-functional teams, driving continuous improvement in data integrity across global trials

Programming & Scripting - Architect and maintain advanced, modular codebases using Python, R, SQL, and SAS to support complex data engineering workflows. Establish coding standards and mentor junior engineers in automation, reproducibility, and performance optimization. Example use cases includes edit checks, reconciliations, exception listings, programmed protocol deviations, resource projections based on site data entry volume

Regulatory Compliance & Documentation - Lead compliance initiatives to ensure all data systems and workflows meet GCP, FDA 21 CFR Part 11, and evolving global regulatory requirements. Define documentation protocols and oversee audit trail governance to support inspection readiness and transparency

Reporting & Visualization - Develop and operationalize dynamic dashboards and analytics tools that provide real-time insights into data quality, trial progress, and operational KPIs. Translate complex datasets into actionable intelligence for clinical and regulatory stakeholders.

Collaboration & Cross-Functional Support - Act as a strategic liaison between Clinical Data Engineering and Biostatistics, Clinical Operations, and Regulatory Affairs. Translate clinical and scientific requirements into scalable technical solutions that support study execution and data delivery.

Database Design & Optimization - Lead the design and optimization of secure, high-performance relational databases and data lakes. Ensure infrastructure scalability, query efficiency, and data governance for large-scale clinical datasets

Qualifications: 

• Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience
• Minimum 6 years experience in clinical monitoring, clinical trial management  or equivalent
• Advanced programming and automation skills; database design; dashboard development; CDISC governance.

Other Required:

• Highly effective oral and written communication skills with the ability to communicate effectively with project team members
• Excellent organizational and time management skills
• Ability to work in a team or independently as required
• Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems and clinical systems
• Proficiency in statistical analysis and data monitoring tools.
• Detail-oriented with strong analytical and problem-solving skills
• Demonstrated experience with integrated risk planning & management
• Ability to mentor junior team members

Preferred:

• CRO experience as a Clinical Data Engineer or Programmer

Skills:

• Strong analytical and problem-solving skills with attention to data quality and integrity.
• Ability to work with large, complex datasets from multiple sources.
• Effective communication skills to collaborate with cross-functional teams.
• Knowledge of data governance, privacy, and security best practices in clinical research.

Competencies

• Collaboration: Works effectively with clinical, statistical, and technical teams to align data strategies with study goals.
• Accountability: Takes ownership of data engineering deliverables and ensures timely, high-quality outputs.
• Adaptability: Thrives in a fast-paced, evolving environment with shifting priorities and timelines.
• Compliance-Oriented: Maintains a strong focus on regulatory compliance and data traceability.

Position Summary:

The Senior Clinical Data Engineer leads the strategic development and optimization of clinical data systems to support regulatory compliance, advanced analytics, and operational excellence across global trials. This role drives enterprise-level data standardization initiatives,  and architects scalable validation frameworks to proactively address systemic data issues. With deep expertise in Python, R, SQL, and SAS, the engineer builds and maintains modular codebases, sets coding standards, and mentors junior engineers. The role also oversees regulatory alignment with GCP and FDA 21 CFR Part 11, establishing robust documentation and audit trail protocols. Through dynamic dashboards and analytics tools, the engineer delivers actionable insights into trial performance and data quality. As a strategic liaison across Biostatistics, Clinical Operations, and Regulatory Affairs, the engineer translates clinical requirements into scalable technical solutions and leads the design of secure, high-performance databases and ETL pipelines integrating data from diverse clinical systems.

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

Data Standardization & Mapping -  Spearhead the development of enterprise-level data mapping strategies that transform raw clinical data into standardized formats for high-impact analytics. Lead the adoption and governance of data standards across programs to ensure regulatory alignment and consistency. 

Data Quality Assurance - Design and implement robust, scalable validation frameworks that proactively detect and resolve systemic data issues. Serve as a strategic partner to Clinical Data Managers and cross-functional teams, driving continuous improvement in data integrity across global trials

Programming & Scripting - Architect and maintain advanced, modular codebases using Python, R, SQL, and SAS to support complex data engineering workflows. Establish coding standards and mentor junior engineers in automation, reproducibility, and performance optimization. Example use cases includes edit checks, reconciliations, exception listings, programmed protocol deviations, resource projections based on site data entry volume

Regulatory Compliance & Documentation - Lead compliance initiatives to ensure all data systems and workflows meet GCP, FDA 21 CFR Part 11, and evolving global regulatory requirements. Define documentation protocols and oversee audit trail governance to support inspection readiness and transparency

Reporting & Visualization - Develop and operationalize dynamic dashboards and analytics tools that provide real-time insights into data quality, trial progress, and operational KPIs. Translate complex datasets into actionable intelligence for clinical and regulatory stakeholders.

Collaboration & Cross-Functional Support - Act as a strategic liaison between Clinical Data Engineering and Biostatistics, Clinical Operations, and Regulatory Affairs. Translate clinical and scientific requirements into scalable technical solutions that support study execution and data delivery.

Database Design & Optimization - Lead the design and optimization of secure, high-performance relational databases and data lakes. Ensure infrastructure scalability, query efficiency, and data governance for large-scale clinical datasets

Qualifications: 

• Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience
• Minimum 6 years experience in clinical monitoring, clinical trial management  or equivalent
• Advanced programming and automation skills; database design; dashboard development; CDISC governance.

Other Required:

• Highly effective oral and written communication skills with the ability to communicate effectively with project team members
• Excellent organizational and time management skills
• Ability to work in a team or independently as required
• Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems and clinical systems
• Proficiency in statistical analysis and data monitoring tools.
• Detail-oriented with strong analytical and problem-solving skills
• Demonstrated experience with integrated risk planning & management
• Ability to mentor junior team members

Preferred:

• CRO experience as a Clinical Data Engineer or Programmer

Skills:

• Strong analytical and problem-solving skills with attention to data quality and integrity.
• Ability to work with large, complex datasets from multiple sources.
• Effective communication skills to collaborate with cross-functional teams.
• Knowledge of data governance, privacy, and security best practices in clinical research.

Competencies

• Collaboration: Works effectively with clinical, statistical, and technical teams to align data strategies with study goals.
• Accountability: Takes ownership of data engineering deliverables and ensures timely, high-quality outputs.
• Adaptability: Thrives in a fast-paced, evolving environment with shifting priorities and timelines.
• Compliance-Oriented: Maintains a strong focus on regulatory compliance and data traceability.

Position Overview 

We are seeking a Technical Product Manager to drive technical requirements and RAN product specifications & solutions for gateway site installation, aligning engineering needs, regulatory constraints, and deployment workflows to enable compliant, commercially viable, and scalable satellite-gateway locations. This role serves as the critical bridge between technical engineering teams, regulatory affairs, commercial development, and site deployment operations to ensure gateway delivers production-ready infrastructure that meets both technical performance requirements and business objectives.

This position requires deep understanding of satellite ground infrastructure, RAN solutions, RF propagation considerations, regulatory compliance frameworks, and site engineering requirements. The ideal candidate will bring proven experience in technical product management within satellite communications infrastructure, with specific expertise in gateway site development, regulatory coordination, and cross-functional technical program management.  

Key Responsibilities 

Technical Requirements & Product Specifications 

• Define comprehensive technical requirements for gateway site acquisition including RF performance criteria, RAN infrastructure specifications, and integration compatibility standards 

• Manage product and deployment requirements for RAN network related hardware 

• Own configuration standards, templates, and governance to ensure consistency across Gateway sites constraints and deployment workflow requirements 

• Coordinate and validate BOMs with Engineering, Supply Chain, and vendors for completeness and accuracy 

• Establish technical validation criteria and acceptance standards for RAN network at Gateway location

• Ensure CIQs, configuration guides, port mappings, and as-built documentation are complete and deployment-ready 

• Coordinate technical requirements gathering sessions with engineering stakeholders, site development teams, and operations personnel 

• Ensure technical specifications support scalable satellite-gateway location development across diverse geographical environments 

• Enable smooth technical handover to Service Acceptance and Operations, ensuring documentation completeness and traceability 

• Support change control by ensuring updates reflected across HLDs, BOMs, configurations, and documentation 

Site Feasibility & Validation Management 

• Lead technical site feasibility assessments including RF propagation analysis, interference studies, and infrastructure capability evaluations for RAN network deployment 

• Validate site feasibility against established technical criteria, and operational deployment standards 

• Coordinate multi-disciplinary feasibility studies involving RF engineering, utilities assessment, and regulatory compliance teams 

• Manage technical risk assessments and mitigation strategies for site acquisition projects 

• Establish standardized feasibility validation processes and documentation frameworks 

Cross-Functional Engineering Coordination 

• Coordinate engineering inputs from RF engineering, satellite systems, network operations, and infrastructure development teams 

• Facilitate technical collaboration between site acquisition teams and broader satellite network engineering organization 

• Ensure consistent engineering standards and technical approaches across multiple gateway site development projects for RAN network 

• Drive technical decision-making processes involving multiple engineering disciplines and stakeholder groups 

• Enable smooth technical handover to Service Acceptance and Operations, ensuring documentation completeness and traceability 

Documentation & Delivery Standards Management 

• Manage comprehensive technical documentation for gateway site including requirements specifications, RAN Rack layout design standards, and validation procedures 

• Ensure site acquisition outputs meet integration, build, and commercial-ready gateway delivery standards 

• Establish and maintain technical documentation standards and configuration management processes 

• Maintain technical traceability from requirements through final delivery and commissioning 

Technical Program Management & Process Optimization 

• Develop and optimize technical workflows for gateway site acquisition from RAN network prospects, including requirements definition, feasibility assessment, and delivery validation processes 

• Drive continuous improvement initiatives for technical processes, tools, and methodologies 

• Coordinate technical resource allocation and capacity planning for site acquisition programs  

Qualifications 

Education 

• Bachelor's degree in Electrical Engineering, Telecommunications Engineering, Systems Engineering, or related technical field 

• Master's degree in Engineering Management, Systems Engineering, or advanced technical discipline preferred 

Experience 

• Minimum 8+ years in satellite communications, telecommunications infrastructure, or wireless network engineering 

• Minimum 5 years’ relevant experience in RAN engineering, telecom site acquisition, or technical product management supporting ground facilities 

• Demonstrated experience producing or validating site engineering deliverables: site survey reports, RF/site feasibility and integration acceptance criteria 

• Strong written communication and technical documentation skills for creating ICDs, acceptance plans and status reports 

• Ability and willingness to travel domestically to candidate and active gateway sites as required for surveys, permitting meetings, and commissioning 

Required Technical Expertise 

• Deep understanding of satellite ground segment architecture, gateway systems, and RF infrastructure requirements 

• Hands on experience of eNB hardware and RAN architecture design 

• Strong knowledge of satellite communications link budgets, antenna systems, and RF propagation characteristics 

• Proven ability to translate complex technical requirements into actionable product specifications and delivery criteria 

• Experienced on CIQ handling and deployment documentation workflows 

Preferred Qualifications 

• Background in technical product management roles at satellite operators, ground infrastructure providers, or telecommunications companies 

• Experience with technical project management methodologies and cross-functional technical program coordination 

• Familiarity with 4G/ 5G NTN standards, satellite-cellular integration, and next-generation satellite communications architectures 

Leadership & Communication Skills 

• Strong technical leadership with ability to influence and coordinate across multiple engineering disciplines 

• Exceptional communication skills for presenting complex technical requirements to diverse stakeholder audiences 

• Proven ability to manage technical programs involving regulatory agencies, engineering teams, and commercial stakeholders 

• Experience building scalable technical processes and product management frameworks 

• Demonstrated success in technical decision-making and conflict resolution across cross-functional teams 

Technology Stack 

• Proficiency with technical documentation systems, requirements management tools, and project management platforms 

• Experience with RF simulation tools, link budget analysis software, and satellite communications modelling systems 

• Knowledge of geographic information systems (GIS) and site assessment tools commonly used in telecommunications infrastructure development  

Physical Requirements 

• Role will be based in India

• Regular travel for site assessments, technical meetings, and stakeholder coordination (~25-30%) 

• Ability to participate in field site evaluations including outdoor assessments at potential gateway locations 
• Ability to work across global time zones and participate in remote review sessions.

This job description may not be inclusive to the duties and responsibilities listed. Additional tasks may be assigned to the employee from time to time or the scope of the job may change as needed by business demands. 

POSITION OVERVIEW:

The Global Regulatory Lead Partner supports Global Regulatory Leads in assigned therapeutic areas and serves as the accountable global regulatory point of contact for designated products. The individual provides regulatory leadership for life‑cycle management, maintenance of established products, and execution of global regulatory submissions. This role drives results through regulatory science expertise, strong communication, and analytical capabilities, ensuring high‑quality regulatory strategies and deliverables for assigned products.

WORK LOCATION:

Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or changed as necessary.)

• Ensure maintenance of global registrations for assigned products, including US and EU markets.
• Lead and execute regulatory activities supporting life‑cycle management, including submission strategy development, timeline definition, prioritization, assembly review, and identification of regulatory risks/challenges.
• Manage regulatory agency communications and submissions, including responses to agency questions, labeling negotiations, updates, and periodic reports.
• Coordinate SMEs to develop response strategies and author/review responses to health authority requests.
• Support labeling discussions, updates, and filings across CCDS, USPI, SmPC, and country‑specific labels.
• Provide regulatory input for annual reports, renewal applications, and aggregate safety reports (e.g., PSURs, PADERs).
• Conduct regulatory review for tender bid applications and assess country requests for registration deletions.
• Support preparation of ancillary documents required for product registrations in global markets.
• Follow through on agency commitments and ensure timely, high‑quality regulatory deliverables.
• Conduct research and review of US, EU, and other relevant regulatory guidelines, precedence, and competitive intelligence to inform regulatory strategy.
• Collaborate with Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, and other functional partners to ensure alignment and execution of regulatory strategy.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor's degree or higher in a relevant field such as pharmaceuticals, chemistry, or regulatory affairs.

Experience:

• 5+ years of experience in regulatory affairs and/or regulatory framework of major health authorities
• Experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with both small molecules and biologics. Has sufficient regulatory knowledge to integrate inputs from other countries/regions to develop a global strategy and can develop and lead execution of holistic regulatory strategy while considering risk/opportunity, timeline, resource.
• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends. Understands scientific and clinical data sufficiently to ask questions and make suggestions about cross-functional topics to influence overall development strategy and to assess regulatory implications and develop regulatory strategy.
• Regulatory experience with pre and post approval lifecycle management, interactions with Health Authorities, leading cross-functional regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
• Strong business acumen and ability to make sound decisions that contribute positively to the business.
• Strong strategic skills and the ability to balance short-term needs with long-term vision.
• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.

Skills and Attributes:

• Excellent written and verbal communication skills.
• Strong negotiating skills and ability to think creatively and develop innovative solutions.
• Strong organizational and project management abilities.
• Strong analytical skills with high attention to detail.
• Understanding of regulatory filing requirements.
• Knowledge of ICH guidance and routine regulatory maintenance requirements.
• Ability to manage multiple priorities and work independently in a fast-paced environment.
• Proactive, detail-oriented, and self-motivated with a strong work ethic.

Join The Simtra Talent Community

Are you passionate about making an impact in the Contract Development and Manufacturing Organization (CDMO) industry? Even if you don’t see a current role that matches your skills and interests, we’d love to stay connected with you!

By joining our Talent Community, you'll be the first to know about exciting new opportunities across a wide range of roles within the CDMO industry, including areas like:

• Research and Development: Contribute to innovative solutions that drive progress.
• Manufacturing and Operations: Ensure high-quality production and efficiency.
• Quality Assurance and Regulatory Affairs: Maintain excellence and compliance.
• Project Management: Lead transformative projects from concept to completion.
• Business Development: Drive growth and foster meaningful partnerships.

As a valued member of our Talent Community, you'll receive:

• Early notifications of new job openings in the CDMO sector.
• Updates on company news and advancements.
• Exclusive insights into what it’s like to work with us.

We’re always looking for talented individuals who are eager to make a difference. Take the first step—join our Talent Community today—and let’s shape the future of the CDMO industry together!

About MasterControl:

MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers to bring life-changing products to more people sooner. The MasterControl Platform helps organizations digitize, automate and connect quality and compliance processes across the regulated product development life cycle. Over 1,000 companies worldwide rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. For more information, visit www.mastercontrol.com.

ROLE: 
Design and own a governed semantic layer and procedural query system that enables AI agents to reliably converse with enterprise data. Build the bridge between user intent → structured queries → reproducible results, ensuring all interactions are accurate, explainable, and deterministic.

RESPONSIBILITIES:

• Define canonical entities, relationships, metrics, and hierarchies
• Enforce consistent business definitions across systems
• Model join paths, grain, and aggregation rules
• Create versioned, reusable metric definitions
• Resolve conflicting logic across teams
• Ensure correctness across all query combinations
• Design APIs for filtering, aggregation, grouping, and joins
• Enable agents to operate via predefined semantic procedures, not raw SQL
• Map intent → validated query plans
• Support systems where users ask questions in natural language
• Ensure responses are grounded in: Semantic layer definitions. Deterministic execution paths
• Control how queries are constructed: Enforce valid joins and filters. Prevent ambiguity and incorrect aggregations
• Inspect and optimize generated SQL
• Maintain traceability from source → semantic model → output
• Implement validation tests and metric checks
• Optimize queries, materializations, and caching
• Ensure low-latency responses for interactive use

REQUIREMENTS:

• 5–7 years of experience in large-scale enterprise data modeling for AI/ML applications
• Strong proficiency in Java or Python, with a preference for Java for production service development and Python for NLP workflows
• Deep understanding of joins, grain, aggregations, and window functions
• Strong experience with semantic layers (e.g. Cube) and modern data warehouses (e.g. Snowflake)
• Experience building metric layers used across teams, and with query abstraction or API-based data access

PREFERRED:

• Experience enabling natural language → data query systems
  Familiarity with:
• Controlled use of LLMs in data applications
• Query planning or rule-based systems

WHAT WE ARE NOT LOOKING FOR:

• Direct AI/LLM access to raw databases
• Ad-hoc or conflicting metric definitions
• Opaque or non-traceable query generation

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• Some travel is required, typically to meet with customers, team and organizational meetings, etc. 

• Must be able to work exceptionally well with people of varying backgrounds and personality types. 

• Ability to operate a computer and work at a desk for extended periods of time. 

• Ability to communicate effectively in writing, in person, over the telephone and through various collaborative tools such as Zoom, Confluence and Slack. 

Why Work Here?

#WhyWorkAnywhereElse?

MasterControl is a place where Exceptional Teams come together to do their best work. In fact, hiring Exceptional Teams is a core value of ours. MasterControl employees are surrounded by intelligent, motivated, and collaborative individuals. We like to call it #TheBestTeamOnThePlanet.

We work hard to develop and challenge our employees' skillsets, recognize their contributions, encourage professional development, and offer a one-of-a-kind culture. This is why we say #WhyWorkAnywhereElse?

MasterControl could be your next (and last) career move!

Here are some of the benefits MasterControl employees enjoy:

• Competitive compensation
• Schedule flexibility
• Fitness clubs (you get paid to have fun and be active!)
• Company parties and employee recognition programs
• Wellness programs
• Much, much more!

MasterControl is an Equal Opportunity Employer. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact MCTalent@MasterControl.com or call (801) 942-4000 and ask to speak with a member of Human Resources.
Equal Opportunity Employer, including disability and protected veteran status.

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

*** this territory will cover: Bloomington, Ft. Wayne, Hammond, Indianapolis, Peoria, South Bend, Springfield

Summary of Job:

The Regional Business Manager is a critical role in establishing KKI as a leader in Rare Diseases by demonstrating our commitment to supporting the efforts of Rare Disease healthcare providers in improving patient health outcomes and becoming a trusted resource in demonstrating value along the patient journey. 

The Regional Business Manager will understand education referral networks to identify appropriate patients and ensure maintenance on Crysvita by supporting appropriate multidisciplinary support of the patients via their care network.  

They will also work closely with the cross-functional teams at KKI.  

The Regional Business Manager serves as the lead point of contact for activities within the assigned hospital networks, academic Institutions, and surrounding practices and works closely with Market Access, Sales, Marketing, and Medical Affairs. 

Essential Functions:

• Maintain a high degree of clinical knowledge to engage effectively with Endocrinologists, Geneticists, and Rheumatologists in the areas of X-Linked Hypophosphatemia (XLH) and Tumor Induced Osteomalacia (TIO). 
• Focus efforts on achieving the greatest positive patient impact. 
• Manage patient identification by understanding the patient journey to aid in the diagnosis and thus enable access to therapy. 
• Clearly understand and implement the marketing plan, accurately articulate the value proposition, and utilize on-label and approved marketing materials only to attain sales/patient objectives for assigned products on a monthly, quarterly, and yearly basis. 
• Communicate all disease, product, and formulary information in a manner that is truthful and non-misleading, consistent with Kyowa Kirin's compliance policies and all applicable laws and regulations. 
• Individual must manage their territory using discretion and judgment when executing the brand strategy to maximize performance within the assigned customer population.  This may include physicians within specialty medical practices and their staff, specialists within local hospitals and clinics, and any other appropriate HCPs within their geographic area. 
• The Rare Disease Sales Specialist must be able to analyze local and regional business/managed markets trends to build both long and short terms goals that lead to a successful business plan. 
• Work compliantly in a matrix environment encompassing Patient Services, Specialty Infusion Pharmacies, and Managed Markets, which includes treating confidential patient information in accordance with Kyowa Kirin practices and policies. 
• Create productive business partnerships with internal customers to create compliant plans for selling approaches that align with the company and territory business plans. 
• Seek clarification from management and/or Compliance & Legal when uncertain whether a proposed activity could violate the law or compliance policies. 
• Utilize a consultative selling approach. This will be a highly technical, solution-oriented selling model enabling the representative to meet the needs of healthcare professionals who treat X-linked hypophosphatemia (XLH) and Tumor Induced Osteomalacia (TIO).  
• Manage a territory marketing and promotional speaker program budget in a manner that is consistent with all Kyowa Kirin compliance policies. 
• Share best practices and actively participate in Regional/National meetings. 
• Utilize CRM system to document account profiles, pre, and post-call activities. 

Compliant  

• Refers requests for off-label information to KKI’s medical department through the MIR process. 
• Strictly adhere to relevant regulatory and compliance guidelines and company policies. 

Job Requirements:

Education 

• Bachelor’s degree in Science or Business, MBA, Pharmacy/Medical Degree. 

Experience 

• Minimum of 5 years of specialty pharmaceutical sales experience. 
• Experience in making profound differences to patients by enabling access to the best treatments available. 
• Ability to discuss therapeutic strategies to inform and influence decision-makers. 
• Ability to successfully develop and apply clinical and business expertise, and effective selling skills. 
• Strong verbal, influencing, presentation, and written communication skills. 
• Reside within proximity to assigned geography. 
• Ability to adapt to changing business needs, conditions, and work responsibilities. 
• Displays an ongoing commitment to learning and self-improvement. 

Preferred: 

• Execution of marketing strategies at the local level. 
• Demonstrated business and strategic planning skills to identify unique selling opportunities and adaptability to changing market conditions. 
• Demonstrated understanding of managed care landscape and how it influences/impacts business. 
• Strong collaboration skills and success working in teams 
• Experience selling a product that requires extensive coordination with patient services. 
• Working knowledge of Rare Disease. 
• Demonstrated ability to analyze complex technical data and to develop strategic and actionable business plans. 

Travel Requirements: 

• Must have a valid driver’s license issued in the US with a clean driving record. This position will involve overnight domestic travel depending on the territory. 

Technical Skills 

• Proficient in MS Office Suite. 

Non-Technical Skills 

• Highly motivated and great attention to detail. Strong endurance to work under tight timelines and complex/changing situations.  Excellent written and oral communication skills. Excellent problem-solving skills. Broad level of interpersonal skills and flexibility.   Cultural sensitivity and ability to develop consensus within a multinational organization. 

The anticipated salary for this position will be $180,500 to $202,400. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes a Summer and Winter Shut-Down, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at  212 Carnegie Center Dr. Suite 510 Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-PE1

#LI-Field

RC Resolve is a strategic communications advisory firm working at the intersection of finance, corporate reputation, public affairs, and brand for healthcare companies, backed by the capabilities and expertise of Real Chemistry.  

We partner with boards and management teams during normal course and transformative periods to design communications strategies that help companies advance business goals, build trust, and seize timely market opportunities. We counsel executives and boards through highstakes moments including M&A, IPOs, restructurings, shareholder activism, crises, and major corporate transformations. 

We are seeking a senior leader to build and lead our Financial and Transaction Communications offering, working with clients across sectors and geographies. 

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

Role Overview 

The Head of Financial and Transaction Communications will be a senior leader responsible for: 

• Building and leading our financial communications practice 

• Serving as a primary advisor to CEOs, CFOs, General Counsel, Heads of IR, and Boards working in concert with their key advisors 

• Driving new business and deepening relationships with existing clients to support issues and opportunities  

• Leading teams through complex, high-stakes, timesensitive, and confidential situations 

This role suits an experienced financial communications professional from a top-tier advisory firm, inhouse IR/corporate comms team, or similar environment, who thrives in fastpaced, transaction driven work and business- and relationship-building opportunities. 

Key Responsibilities 

Client Advisory & Strategy 

• Serve as trusted counselor to senior executives on all aspects of financial and capital markets communications. 

• Develop and oversee integrated communications strategies around:

• IR Advisory
• M&A
• IPOs and SPACs
• Activist Defense & Preparedness
• Restructuring
• Bankruptcy
• Executive Transitions
• Divestitures & Spins
• Investor and R&D Days
• Financial Media Relations & Storytelling

• Craft clear, compelling narratives that translate complex financial and strategic issues for investors, media, employees, regulators, and other stakeholders. 

• Provide real-time strategic counsel in high pressure, confidential situations, often in partnership with legal and banking advisors. 

Transaction/Event-driven Communications 

• Lead communications workstreams for event-driven situations (to include but not limited to: M&A, IPOs/Spins/SPACs, activism, bankruptcies/restructurings, crisis (cyber, litigation and beyond), Board/management transitions.), including: 

• Prospecting, relationship building with key advisors (bankers, lawyers, etc.) focused on HC sector. 

• Leading transaction / event-driven work. 

• Development of comms strategy, materials, media and social considerations. Support of the lead up to announcement, announcement day as well as integration support. 

• Deal playbook and scenario planning to protect and preserve reputation and valuation throughout the deal process 

• Development of strategy, scenario planning, communications playbook, etc. for lead up to, day of and post-announcement situation  

• Drafting key materials (press releases, Q&As, investor decks, fact sheets, talking points, etc.) 

• Coordinating with key advisors (lawyers, bankers, etc.) and ensure alignment with regulatory and disclosure requirements 

IR Advisory & Related Services 

• Develop and refine clients’ equity story/investor narrative 

• Oversee creation and quality of investor facing collateral, including: 

• Investor presentations 

• Investor day/R&D day materials  

• Infographics 

• IR website alignment with collateral 

• Earnings Advisory: Advise and support the development of earnings materials: to include press release, deck, scripts, Q&A prep  

• Advise on engagement with sellside and buyside analysts in coordination with IR and legal teams. 

• Annual reports as well as sustainability reports (in partnership with design/ESG teams as needed). 

• Advise on integration of financial communications with broader corporate reputation, ESG, and public affairs strategies. 

Financial Media & Stakeholder Engagement 

• Lead financial and business media strategy, cultivating relationships with key journalists and outlets. 

• Prepare executives for highstakes media interviews, investor meetings, earnings calls, and roadshows. 

Practice & People Leadership 

• Build and lead a high-performing financial communications team within the agency, including integration of legacy IR team, recruitment, training, and mentorship. 

• Set practice standards, playbooks, and bestinclass approaches for transaction and capital markets mandates. 

• Foster collaboration across practices (corporate, crisis, public affairs, digital, ESG, brand) to deliver integrated solutions. 

• Contribute to firm leadership, culture, and DEI objectives. 

Business Development 

• Drive growth of the financial communications practice through: 

• Identifying and pursuing new business opportunities 

• Leading and contributing to pitch development and presentations across significant client base 

• Build rapport and become a trusted, go-to referral partner for network among corporates, private equity, banks, law firms, and other advisors. 

• Help shape the agency’s market profile via thought leadership (reports, opeds, conferences, webinars) on capital markets, M&A, activism, and related themes. 

Qualifications 

• 15+ years of experience in financial communications, investor relations, investment banking, equity research, or related fields, with a strong advisory component. 

• Proven track record working on complex, highstakes situations such as: 

• M&A (including crossborder, contested, and private equitybacked deals) 
• IPOs and significant capital markets transactions 
• Shareholder activism and governance/ESG-related campaigns 
• Restructurings, turnarounds, and crisis situations with market impact. 
• Experience in a leading strategic communications/PR firm (e.g., financial/transaction communications practice) or top-tier in-house corporate role strongly preferred.  

• Experience working with healthcare clients a plus      

Skills & Capabilities 

• Deep understanding of capital markets and the needs of institutional investors and analysts. 

• Exceptional writing skills: capable of producing clear, concise, and persuasive materials under tight deadlines. 

• Strong judgment and discretion, with demonstrated ability to advise senior executives and boards in sensitive situations. 

• Comfortable operating in fast-paced, ambiguous, and time pressured environments; calm and solutions-oriented under stress. 

• Strong project and team management skills; able to run multiple complex engagements simultaneously. 

• Collaborative and low ego; able to integrate with cross-functional teams including legal, banking, IR, public affairs, digital, and creative. 

Education & Other 

• Bachelor’s degree required; advanced degree (MBA, JD, or related) a plus but not required. 

• Understanding of US regulatory and disclosure frameworks; global regulatory expertise not required but helpful 

• Willingness to work extended hours during live situations and to travel as required. 

  Pay Range: $300,000 - $360,000

  This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time

POSITION OVERVIEW:

Syner-G seeks a Manager/Senior Manager of Regulatory Affairs to provide regulatory consulting to a large, global pharmaceutical Client in the areas of Chemistry, Manufacturing, and Controls (CMC), to ensure compliance with FDA, EMA, and global regulatory requirements (with a focus on post-approval).  A successful candidate will have a proven track record of applying scientific principles to solve challenges.

WORK LOCATION:

Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or changed as necessary.)

• Demonstrating strong ownership, initiative and accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
• Actively contributes to strategic discussions and decision-making processes.
• Possesses excellent communication skills, exhibit strong leadership potential in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
• Contribute to the development of CMC regulatory strategies and submission documents for post approval pharmaceutical products with the ability to execute tasks independently in accordance with US, EMA & global regulations and ICH guidance.
• Execute regulatory strategies by leading the authoring and review of global CMC submissions and ancillary documentation to support post-approval supplements/variations, and responses to health authority questions using established business process and submissions tools.
• Collaborate with CLIENT and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Coordinate timely and accurate responses to the Regulatory agency questions (RTQs) on CMC content.
• Responsible for regulatory operational activities including organizing, tracking, and sending submissions for publishing for the US and other International Markets.
• Provide regulatory change control assessments and strategize post-approval implementation and applicable regulatory reporting.
• Perform regulatory reviews of technical/development documents such as certificate of analysis (CoA), analytical test methods, specifications, and stability protocol/report/data.
• Support and prepare other CMC ad-hoc requests at the pre & post-approval stage of the product.
• Author/compile documentation for regulatory submission packages including post approval submissions, information request updates, and new markets registration, source of supply changes for submission to global regulatory agencies.
• Proactively ensure all regulatory documents are prepared accurately and completed in a timely manner towards project completion.
• Maintains knowledge of current FDA, EU, global regulations and guidance’s applicable to marketed products.
• Assess and communicate potential regulatory risks and product mitigation strategies.
• Identify, communicate and escalate potential regulatory issues to concerned CMC team/management, as needed.
• May manage a team of two (2) to four (4) individual contributors in support of project execution.
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
• Potential for pre-approval submissions (IND/CTA/IMPD) authoring depending upon prior experience and expertise.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor’s or Master’s degree required in sciences, Pharmacy, Biological sciences, Engineering, or related field, Advanced degree preferred.

Experience:

• Minimum seven (7) years of CMC post approval submissions or relevant experience, which may include regulatory, research, manufacturing, analytical methods development, quality control, or related fields.
• Minimum 5 years’ experience in post approval CMC authoring and review of CMC sections in Module 1, 2, and 3 for the post-approval regulatory filings required.
• Demonstrated superior oral and written communication skills, as well as interpersonal skills; detail-oriented and well organized.
• Working knowledge of the US and European regulations and ICH guidances.
• Extensive knowledge of pharmaceutical development, specifications, release and stability of drug products and substances.
• Strong knowledge and experience of working in cGMP environment preferred.
• Hands on experience in regulatory systems and tools for authoring and change controls assessment is a plus (i.e. EDMS, Veeva Vault, Trackwise).
• Demonstrated ability to prioritize and handle multiple projects simultaneously.
• Proactive and self-motivated; ability to take initiative.
• Strong work ethic and desire to thrive in a fast-paced, deadline-driven environment.
• Prior Supervisory experience in pharmaceutical industry is a plus.

Skills and Attributes:

• Excellent written and verbal communication skills
• Strong organizational and project management abilities
• Ability to manage multiple priorities and work independently in a fast-paced environment
• Proactive, detail-oriented, and self-motivated with a strong work ethic

About MasterControl:

MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers to bring life-changing products to more people sooner. The MasterControl Platform helps organizations digitize, automate and connect quality and compliance processes across the regulated product development life cycle. Over 1,000 companies worldwide rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. For more information, visit www.mastercontrol.com.

SUMMARY
We are seeking an intern for the role Integrations Engineer in our Professional Services team with emphasis on developing and maintaining enterprise-level integrations and tools. The ideal candidate will have strong understanding of server-side programming languages and great aptitude for understanding, learning and ultimately performing integrations with MasterControl products and other systems.
 
RESPONSIBILITIES
•    Understand and train on MasterControl suite of products.
•    Work with existing Integration Engineers to learn integration methodologies
•    Work and assist existing Integration Engineers to complete development tasks, documentation with the goal of performing the end-to-end integration by self.
•    Monitor, support, and troubleshoot existing integrations
•    Engage with your team, participate in code reviews, with a quality mindset across the team and encourage AI-enhanced design principles
•    Be customer-focused, with a high emphasis on quality in execution
•    Assist existing team in data services such as report building, migrations that impacts customers.
 
QUALIFICATIONS
•    Pursuing or recently completed a degree in Computer Science, Software Engineering, or a related field.
•    Understanding of any object-oriented programming languages such as Java with some project experience.
•    Basic familiarity with JavaScript, TypeScript, Java, Python, or other relevant programming languages
•    Understanding of any cloud-based platforms such as AWS, Azure.
•    Familiarity with cloud platforms (AWS, Azure, GCP)
•    Understanding of XML, JSON, and other data formats
•    Understanding of database systems and SQL
•    Experience with version control systems (Git)
•    Eagerness to learn and work with AI-driven development tools and solutions
•    Strong critical thinking, problem-solving, and communication abilities
•    A strong sense of responsibility and drive to grow and contribute 
•    Good Standing in current curriculum with no backlogs and NOC from the college or university for the program
 
PHYSICAL DEMANDS AND WORKING CONDITIONS
•    Ability to operate a computer and work at a desk for extended periods of time
•    Ability to communicate effectively in writing, in person, over the telephone and in e-mail
•    Ability to work occasional overtime and travel depending on the organization's needs
•    Ability to work close to 40 hours per week within a professional environment and/or work location.

Why Work Here?

#WhyWorkAnywhereElse?

MasterControl is a place where Exceptional Teams come together to do their best work. In fact, hiring Exceptional Teams is a core value of ours. MasterControl employees are surrounded by intelligent, motivated, and collaborative individuals. We like to call it #TheBestTeamOnThePlanet.

We work hard to develop and challenge our employees' skillsets, recognize their contributions, encourage professional development, and offer a one-of-a-kind culture. This is why we say #WhyWorkAnywhereElse?

MasterControl could be your next (and last) career move!

Here are some of the benefits MasterControl employees enjoy:

• Competitive compensation
• Schedule flexibility
• Fitness clubs (you get paid to have fun and be active!)
• Company parties and employee recognition programs
• Wellness programs
• Much, much more!

MasterControl is an Equal Opportunity Employer. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact MCTalent@MasterControl.com or call (801) 942-4000 and ask to speak with a member of Human Resources.
Equal Opportunity Employer, including disability and protected veteran status

Role :           Lead Corporate Counsel

Location:   Gurgaon

Industry: Real Estate

About Shubhashray Housing

Shubhashray Housing is a mission driven company. It is a professionally run, debt free company with over 185 employees and projects across 9+ locations in NCR, Gujarat and Rajasthan.  

Learn more:
Website: https://shubhashray.com/about-us/
Impact Video: https://youtu.be/Rd8cLpBq5NU

Our Culture 

We maintain the highest standards of integrity with all stakeholders and partners: our customers, employees, contractors and our site workmen. We take pride in enhancing our customers’ lives even after we have handed over the homes. We have zero tolerance for politicking. We like low-ego and conscientious people whose life mission is to constantly learn. We practice a culture that rewards initiative, a low-cost mindset and deliverability, with little regard for hierarchy or centralisation.  

 If you have the right mix of intelligence, passion and high integrity needed to help us accomplish our goals, we strongly encourage you to apply.

Role Summary 

As the Lead Corporate Counsel, you will own all legal affairs including customer, vendor, and regulatory correspondence and documentation, corporate advisory, fund raising, project financing and complaints handling/litigation for  Shubhashray (and its soon-to-be-launched premium housing brand).

You will brief and coordinate with leading external counsels, including Senior Counsel and former ASG Mr. Paras Kuhad, while reporting directly to the CEO and Directors.

For exceptional performers who demonstrate strategic and business acumen, this role offers a defined path to evolve into P&L-linked leadership—taking charge of a business vertical or project. If you aspire to grow from legal stewardship to business leadership, this opportunity is designed for you.

Key Responsibilities 

• Drafting
• Draft, review and negotiate sale deeds, development agreements, JDAs, PoAs, lease deeds and related documentation for land and development.
• Approvals, compliance and regulatory
• Ensure compliance with applicable real estate, municipal and township laws (including RERA and local building/planning regulations) across all projects.
• Maintain a legal calendar and MIS for all regulatory compliances including licences, sanctions and renewals.
• Contracts and commercial support
• Draft, review and negotiate a wide range of contracts: customer agreements, vendor/contractor agreements, consultant agreements, service contracts, NDAs and MOUs
• Proactively identify legal and commercial risks in contracts, propose practical solutions and balance legal protection with business speed.
• Customer, sales and collections
• Standardise and periodically update sales documentation 
• Support the sales and collections teams on customer disputes, delay claims, cancellations and settlements, aiming for fast, fair and legally sound resolutions.
• Disputes and litigation
• Manage all litigation and prelitigation, including RERA, consumer, civil, criminal and labour matters relevant to the projects.
• Coordinate with external counsel, prepare briefs, review pleadings/written statements and track hearings and outcomes in a structured manner.
• Business partnership and leadership track
• Work closely with the founder/management on deal structuring, riskreward analysis and strategic decisions for new projects and partnerships. 
• Over time, take ownership of a defined business vertical or project (e.g., one city, one line of business), going beyond pure legal to P&Llinked responsibilities. 

Candidate Profile 

Must have qualifications 

• A.LLB. from a toptier law school; CA/LLM or additional qualifications are a plus. 
• At least 5–7 years of post-qualification experience, with significant time in real estate/ corporate commercial work (law firm or strong inhouse role). 
• Strong academic record.

Skills and attributes:

• Exceptional written and spoken English, with precise drafting. 
• High IQ and problem-solving ability: ability to quickly understand new structures, laws, and business models and simplify complexity for non- 
• High energy and ownership mindset: comfortable handling a high-intensity, multistakeholder environment across sites, HO and external parties. 
• Strong business sense: able to see the commercial picture behind every legal issue and suggest solutions that enable, rather than block, business.
• Impeccable integrity and judgment, especially in dealing with government authorities, customers, vendors and internal teams.

What This Role Offers 

• End-to-end ownership of all legal work in a fast growing, founder-led real estate platform in NCR and Rajasthan.  
• Direct exposure to land deals, project launches, sales, financing and disputes rather than being limited to a narrow subfunction.
• A defined path to grow into a broader business leadership role (e.g., project head / business vertical owner) for someone who demonstrates capability beyond legal.

CTC:  Up to 25 lacs per annum 

If you thrive in high-ownership environments & want to build, not just manage systems, this role is for you. Be part of a transformation journey where business growth and meaningful impact go hand in hand.