Principal Medical Writer
Location: Remote, India
Job ID: R-01316074
Job Type: Full-time
Department: Clinical Research
Estimated Salary: ₹30 – ₹45 LPA (based on experience and skill set)
About Thermo Fisher Scientific – PPD Clinical Research Services:
Thermo Fisher Scientific is a global leader in serving science, delivering critical clinical research services under the PPD® portfolio. With a presence in over 100 countries, we support drug development programs through laboratory services, digital solutions, and decentralized trials. Join our mission to make the world healthier, cleaner, and safer.
Position Summary:
We are currently expanding our Medical Writing Functional Service Provider (FSP) Team in India and are seeking an experienced Principal Medical Writer (PMW). This remote role offers the opportunity to lead regulatory writing for a dedicated client while contributing to innovative systems like Structured Content Authoring (SCA) and AI-driven content solutions. The PMW will be responsible for the creation, review, and management of complex clinical and regulatory documentation, mentoring junior writers, and delivering high-impact medical content.
Key Responsibilities:
Lead authoring, editing, and management of complex clinical regulatory documents (e.g., CSRs, protocols)
Collaborate cross-functionally with teams including clinical development, regulatory, biostatistics, and medical affairs
Provide strategic input on content structure and regulatory requirements
Ensure all documents meet internal standards and align with global regulatory guidelines
Review and QC deliverables for accuracy, clarity, and compliance
Mentor and supervise junior medical writers
Manage multiple writing projects with attention to deadlines and priorities
Stay updated with evolving regulatory trends and technological innovations in medical writing
Education and Experience Requirements:
Bachelor’s degree in a scientific discipline required; advanced degree (Master’s or Ph.D.) preferred
Minimum 8+ years of experience in regulatory medical writing within the pharmaceutical/CRO industry
Strong track record in writing Phase 3 Clinical Study Reports (CSRs) and clinical protocols
Experience in EU Clinical Trial Regulation (CTR) documentation preferred
Familiarity with Structured Content Authoring systems, AI/NLG tools, and content automation
Proven ability to manage and direct complex writing projects independently
Skills and Competencies:
Exceptional written and verbal communication skills
Strong project and time management capabilities
In-depth knowledge of ICH, EMA, FDA, and other relevant regulatory guidelines
Demonstrated leadership skills, especially in mentoring junior staff
High-level problem-solving and decision-making ability
Strong attention to detail and organizational skills
Experience with digital content platforms and regulatory submission systems
What We Offer:
Competitive salary and benefits package
Flexible work-from-home structure and work-life balance
Access to award-winning learning and development programs
Opportunity to be part of a global CRO with a collaborative local feel
Inclusive culture that values diversity of thought and experience
A chance to contribute to global health through cutting-edge clinical research
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Rangpo |India :
Siliguri |Illinois :
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