Title: FSP Medical Writing Program Manager – Remote, India
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research – Medical Writing / Program Management
Company Overview:
Thermo Fisher Scientific, through its PPD® clinical research services, is a global leader in advancing life-changing therapies. With clinical trials conducted in over 100 countries and expertise spanning laboratory, digital, and decentralized clinical trial services, we deliver innovative solutions that accelerate drug development and improve global health outcomes.
Role Overview:
We are expanding our Medical Writing FSP Team in India and seeking a Program Manager to lead large-scale narrative projects. This role requires strong client engagement, program oversight, and the ability to mentor and train medical writers. The Program Manager ensures high-quality deliverables, timely execution, and alignment with regulatory standards across complex medical writing programs.
Key Responsibilities:
Program Management & Oversight
Develop, monitor, and adapt project plans, timelines, budgets, and forecasts for multi-writer medical writing programs.
Act as the primary contact for risk escalation, proactively identifying and resolving or escalating issues related to project quality, budget, or timelines.
Ensure compliance with quality processes, maintaining consistency within and between project documents.
Develop and manage performance metrics for assigned programs to optimize efficiency and quality.
Medical Writing Leadership
Provide senior-level review of clinical and regulatory documents, including study- and program-level narratives.
Serve as a primary author for complex medical writing deliverables when needed.
Mentor and train medical writers on program management processes, technical writing standards, and regulatory requirements.
Client Engagement & Collaboration
Liaise with internal and external stakeholders to ensure alignment of project goals, timelines, and quality expectations.
Facilitate effective communication within study teams, providing guidance on document strategy, regulatory compliance, and therapeutic content.
Qualifications & Experience:
Bachelor’s degree in a scientific discipline (advanced degree preferred).
8+ years of experience in medical writing or related pharmaceutical/CRO projects.
Proven experience managing large-scale medical writing narrative programs.
Prior experience in the pharmaceutical or CRO industry is preferred.
Additional medical writing certifications (AMWA, EMWA, RAC) are advantageous.
Skills & Competencies:
Strong project management expertise, including resource planning and timeline management for multi-writer projects.
Advanced medical writing, data interpretation, and editorial skills.
In-depth knowledge of global, regional, and national regulatory document guidelines.
Excellent oral and written communication, presentation, and negotiation skills.
Ability to mentor and lead junior staff effectively.
Self-motivated, adaptable, and capable of independent decision-making and problem-solving.
Why Join Us:
Collaborate with a global team of 100,000+ colleagues in a flexible and supportive work environment.
Access to award-winning learning and development programs for career growth.
Competitive salary with comprehensive benefits focused on health, well-being, and work-life balance.
Opportunity to contribute to high-impact medical writing programs that advance patient care worldwide.
Apply Today: Join Thermo Fisher Scientific’s PPD® clinical research services and help make the world healthier, cleaner, and safer. Shape your career while leading complex medical writing programs in a remote, India-based role.
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