Medical Writing Program Manager – CSR Narratives
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Location: Remote, India
Work Mode: Fully Remote
Job Type: Full-Time
Job Category: Clinical Research
Job ID: R-01339499
Experience Required: Minimum 8+ years of experience in medical writing, clinical research documentation, or regulatory writing within the pharmaceutical or CRO industry
Education: Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related scientific discipline; Advanced degree preferred
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in scientific research services and healthcare innovation. Through its PPD clinical research services division, the company supports pharmaceutical, biotechnology, and medical device organizations in accelerating drug development and bringing innovative therapies to patients worldwide.
With clinical trials conducted in more than 100 countries and advanced capabilities in digital and decentralized clinical research, Thermo Fisher Scientific delivers comprehensive solutions across laboratory services, clinical development, and regulatory support.
Job Overview
Thermo Fisher Scientific is expanding its Medical Writing Functional Service Provider (FSP) team in India and is seeking a Medical Writing Program Manager specializing in CSR Narratives. This role focuses on managing large-scale narrative development projects for clinical studies while ensuring high-quality regulatory documentation and project delivery.
The Program Manager will oversee medical writing teams, manage complex project timelines and budgets, and collaborate closely with global stakeholders to ensure regulatory compliance and high-quality documentation standards.
Key Responsibilities
Program and Project Management
Develop, monitor, and manage project plans, timelines, and budget forecasts for large-scale medical writing programs.
Coordinate multi-writer narrative projects and ensure timely completion of deliverables.
Track project performance metrics and monitor program progress against established objectives.
Clinical Study Report Narrative Management
Oversee the development of Clinical Study Report (CSR) narratives and related clinical documentation.
Ensure narrative documents meet regulatory standards and internal quality guidelines.
Provide senior-level review and quality oversight for medical writing deliverables.
Risk Management and Quality Oversight
Act as the primary contact for risk escalation related to project quality, timelines, or budgets.
Identify potential project risks and implement mitigation strategies to maintain program efficiency.
Ensure compliance with global regulatory guidelines and internal documentation standards.
Medical Writing and Regulatory Documentation
Contribute to the development and review of study-level and program-level regulatory documents.
Provide scientific input and editorial oversight for complex clinical documentation.
Maintain consistency across medical writing deliverables within large clinical programs.
Team Leadership and Training
Mentor and train medical writers on narrative development processes and project management practices.
Provide technical guidance on medical writing standards and regulatory documentation requirements.
Support the professional development of junior medical writers within the team.
Stakeholder Collaboration
Engage with global clinical teams, sponsors, and internal stakeholders to coordinate documentation activities.
Facilitate effective communication across project teams to ensure alignment on deliverables and timelines.
Required Skills and Competencies
Strong project management experience in large medical writing or clinical documentation programs.
Advanced medical writing and editing skills, including grammar, editorial review, and document quality control.
Expertise in Clinical Study Report narratives and regulatory document development.
Strong data interpretation and scientific analysis capabilities.
Knowledge of global clinical research guidelines and regulatory documentation standards.
Excellent presentation, communication, and stakeholder engagement skills.
Preferred Qualifications
Experience managing large multi-writer narrative development projects.
Previous experience working within pharmaceutical companies or contract research organizations (CROs).
Professional certifications in medical writing or regulatory affairs such as AMWA, EMWA, or RAC are advantageous.
Professional Skills
Strong leadership and team management capabilities.
Ability to manage multiple complex projects simultaneously.
Strong negotiation and decision-making skills.
Self-motivated with the ability to work independently in remote environments.
Work Environment
Fully Remote Position (India)
Standard Working Schedule: Monday to Friday
Collaborative global clinical research environment
Career Development and Benefits
Thermo Fisher Scientific offers a supportive work environment focused on professional growth, continuous learning, and career advancement. Employees benefit from structured development programs, collaborative global teams, and flexible working arrangements that support work-life balance.
Equal Opportunity Employer
Thermo Fisher Scientific is committed to building an inclusive workplace where diverse backgrounds, experiences, and perspectives are valued. The company provides equal employment opportunities to all qualified individuals without discrimination based on race, gender, religion, age, disability, or other legally protected characteristics.
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