Lead protocol and amendment writing for Syneos Health from a Canada-based remote setting, applying medical writing expertise and regulatory knowledge.

This Senior Medical Writer partners closely with Clinical Scientists on sponsor-dedicated studies. You will coordinate deliverables across departments, resolve client comments, and complete documents accurately with minimal supervision. The work requires experience in protocol writing, late development, and relevant regulatory submissions.

Key Responsibilities:

- Lead clinical study protocols and protocol amendments
- Coordinate medical writing activities across departments
- Resolve client comments and manage document reviews
- Review statistical analysis plans and output specifications
- Ensure compliance with ICH E3 and approved templates

Requirements:

- Three to five years of relevant medical writing experience
- Proven experience writing clinical study protocols
- Biopharmaceutical, device, or contract research organization experience
- Strong understanding of FDA and ICH regulations
- Experience with Veeva or CARA and AMA style

Apply protocol writing, regulatory knowledge, and explicit scientific communication to sponsor-dedicated medical writing at Syneos Health.

📌 Senior Protocol Medical Writer Canada (Montreal)
🏢 Syneos Health
📍 Montreal