Senior Medical Writer – CSR, Protocols & Regulatory Docs

About the role

Syneos Health is seeking a Senior Medical Writer to lead the creation of regulatory and clinical documents such as CSR, protocols, investigator brochures and other regulatory submissions. The role involves coordinating writing activities across departments and ensuring scientific accuracy.

Key responsibilities

• Lead the preparation of clinical study protocols, amendments, CSR, IB, informed consents, safety reports, IND/NDA submissions and related regulatory documents.
• Coordinate quality and editorial reviews, manage source documentation, and resolve client comments.
• Review statistical analysis plans, tables, figures and listings for content, grammar and consistency.
• Mentor less‑experienced writers and contribute to internal process improvements.

Required profile

• 3‑5 years of regulatory medical writing experience in biopharma, device or CRO environment.
• Strong understanding of EMA, FDA and ICH regulations and good publication practices.
• Excellent English grammar and ability to communicate clearly.

Required skills

• Regulatory writing (CSR, protocols, IB, IND/NDA, eCTD).
• Familiarity with ICH E3 guidelines and AMA Manual of Style.
• Experience reviewing statistical analysis plans and related outputs.
• Online clinical literature searching and copyright compliance.