Medical Writing Program Manager | CSR Narratives
Company: Thermo Fisher Scientific
Location: Remote, India
Job Type: Full-Time | Fully Remote
Experience: 8+ Years (Medical Writing / Clinical Research / Program Management)
Qualification: Bachelor’s in Scientific Discipline (Advanced Degree Preferred)
Salary Range: Not Specified
Job Overview
Thermo Fisher Scientific is seeking a Medical Writing Program Manager | CSR Narratives to lead large-scale medical writing projects within the Functional Service Partnership (FSP) model.
The role involves managing end-to-end narrative writing programs, including planning, execution, quality oversight, and stakeholder communication. The Program Manager will act as the primary point of contact for clients, ensuring timely delivery, quality compliance, and alignment with global regulatory standards.
This position also includes mentoring medical writers, overseeing performance metrics, and contributing to regulatory document development, playing a key role in clinical documentation strategy and delivery.
Key Responsibilities
Program Management & Execution
Develop, monitor, and manage project plans, timelines, and budgets for large-scale narrative projects.
Adapt project strategies based on evolving requirements and priorities.
Ensure timely delivery of all project milestones.
Risk Management & Escalation
Serve as the primary point of contact for risk identification and escalation.
Evaluate risks related to quality, timelines, and budget.
Resolve issues or escalate appropriately to stakeholders.
Quality & Compliance
Ensure compliance with quality standards and regulatory requirements.
Maintain consistency across all project documents.
Perform senior-level review of project deliverables.
Metrics & Performance Monitoring
Develop and manage performance metrics for assigned programs.
Track project progress and ensure alignment with defined KPIs.
Identify gaps and implement corrective actions.
Medical Writing & Documentation
Contribute as a primary author for regulatory and clinical documents when required.
Provide input at both study-level and program-level documentation.
Ensure adherence to global and regional document development guidelines.
Training & Mentorship
Train and mentor medical writers on processes and technical aspects.
Support development of junior and entry-level team members.
Guide teams in best practices for narrative writing and program execution.
Stakeholder Management
Collaborate with internal teams and clients to ensure smooth project execution.
Communicate effectively with stakeholders across functions.
Lead study teams and coordinate cross-functional activities.
Required Skills
Project Management
Strong experience in managing large-scale medical writing projects.
Ability to handle multiple timelines, resources, and deliverables.
Medical Writing Expertise
Strong knowledge of CSR narratives and regulatory documentation.
Excellent writing, editing, and proofreading skills.
Regulatory Knowledge
Understanding of global, regional, and national regulatory guidelines.
Familiarity with document development standards in clinical research.
Communication & Leadership
Excellent verbal and written communication skills.
Strong leadership and team management abilities.
Ability to mentor and guide team members effectively.
Analytical & Decision Making
Strong problem-solving and decision-making skills.
Ability to interpret data and make informed project decisions.
Basic Qualifications
Bachelor’s degree in a scientific discipline or equivalent qualification
8+ years of relevant experience in medical writing and program management
Experience managing large narrative writing projects
Experience in pharmaceutical or CRO environment
Preferred Competencies
Advanced degree in scientific discipline
Certifications such as AMWA, EMWA, or RAC
Strong negotiation and stakeholder management skills
High level of independence and adaptability
Key Competencies
Program and project management
Medical writing and regulatory documentation
Quality and compliance oversight
Training and team development
Stakeholder communication and leadership
About the Company
Thermo Fisher Scientific is a global leader in serving science, providing innovative solutions in clinical research, laboratory services, and drug development. Through its PPD clinical research portfolio, the company supports pharmaceutical and biotechnology organizations worldwide in accelerating the development of life-changing therapies.
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