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
Solid 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 Toronto
🏢 Syneos Health
📍 Toronto