Thermo Fisher Scientific is a global leader in scientific research and healthcare innovation, dedicated to enabling customers to make the world healthier, cleaner, and safer. With clinical trials conducted in over 100 countries, Thermo Fisher Scientific (through its PPD® Clinical Research division) is at the forefront of drug development, delivering life-changing therapies through cutting-edge clinical research services.
As part of our growing Full-Service Provider (FSP) Medical Writing team in India, we are seeking an experienced Principal Medical Writer (PMW) to support a key client. The ideal candidate will have expertise in Structured Content Authoring (SCA) systems, AI-driven content creation, and regulatory medical writing, ensuring high-quality clinical and regulatory documents.
Job Description: Principal Medical Writer
Key Responsibilities:
✔ Lead the development, writing, and editing of complex clinical and regulatory documents (CSRs, protocols, EU CTR submissions, etc.).
✔ Collaborate with cross-functional teams (Clinical Development, Regulatory Affairs, Biostatistics) to ensure high-quality, compliant documents.
✔ Ensure alignment with ICH-GCP, FDA, EMA, and other regulatory guidelines.
✔ Provide strategic input on document structure, content, and regulatory requirements.
✔ Mentor and oversee junior medical writers to maintain quality standards.
✔ Manage multiple projects, ensuring timely and accurate deliverables.
✔ Stay updated on industry trends, AI-driven content automation, and regulatory changes.
Education & Experience:
✔ Bachelor’s degree in Life Sciences or related field (Advanced degree preferred).
✔ 8+ years of Regulatory Medical Writing experience in Pharma/CRO.
✔ Strong experience in Phase III Clinical Study Reports (CSRs) and protocol development.
✔ Experience with EU CTR submissions is a plus.
✔ Familiarity with Structured Content Management (SCM) systems, AI/Natural Language Generation (NLG) preferred.
Skills & Competencies:
✔ Exceptional scientific writing & editing skills.
✔ Strong project management & leadership abilities.
✔ Deep understanding of regulatory guidelines (ICH, GCP, FDA, EMA).
✔ Collaborative mindset with excellent stakeholder communication.
✔ Ability to work independently & make strategic decisions.
Why Join Thermo Fisher Scientific?
✅ Global Impact: Contribute to life-changing therapies & innovative clinical research.
✅ Career Growth: Award-winning training & development programs.
✅ Work-Life Balance: Flexible & fully remote work culture.
✅ Inclusive Culture: Diverse, collaborative, and innovation-driven environment.
