Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With 29,000+ employees across 110 countries, Syneos Health combines clinical, medical affairs, and commercial expertise to drive better outcomes in drug development.
The company fosters a collaborative, inclusive culture focused on career growth, innovation, and patient impact. Syneos Health has contributed to 94% of all novel FDA-approved drugs in the past five years, working on over 200 studies involving 73,000+ sites and 675,000+ trial patients.
Detailed Job Description
Job Title: Medical Writer II (QC of Regulatory Documents)
Location: Remote (India)
Job ID: 25100508
Key Responsibilities:
- QC review of regulatory documents, including protocols, CSRs, IBs, amendments, and safety reports.
- Write, edit, and format clinical study reports (CSRs), protocols, investigator brochures (IBs), and patient narratives.
- Ensure compliance with ICH E3, FDA, and EMA guidelines, as well as company/client templates.
- Coordinate quality and editorial reviews, resolving client feedback efficiently.
- Peer-review internal documents for scientific accuracy, clarity, and consistency.
- Collaborate with cross-functional teams (biostatistics, regulatory, clinical operations).
- Conduct literature searches and ensure copyright compliance.
- Mentor junior medical writers and assist in training.
Required Skills & Experience:
✔ Bachelor’s degree (Life Sciences, Pharmacy, Medicine); advanced degree preferred.
✔ 2+ years of experience in medical/regulatory writing (protocols, CSRs, IBs).
✔ Strong knowledge of FDA/ICH guidelines and AMA style.
✔ Experience in pharma, CROs, or biotech preferred.
✔ Excellent English grammar, editing, and scientific writing skills.
Why Join Syneos Health?
✅ Career Growth: Professional development & mentorship programs.
✅ Flexible Work: Fully remote opportunity.
✅ Inclusive Culture: Emphasis on diversity, equity, and belonging.
✅ Impactful Work: Contribute to life-changing therapies.
