Regulatory medical writing expertise drives clear clinical documents at Syneos Health for sponsor-dedicated work across North America, Canada, and the United Kingdom.

This senior-level position leads medical writing deliverables for individual studies with minimal supervision. You will coordinate cross-functional activities, resolve client comments, and prepare regulatory documents. The work includes protocols, clinical study reports, investigator brochures, submissions, and safety reports.

Key Responsibilities:

- Lead explicit, accurate medical writing deliverables for individual studies
- Prepare protocols, clinical study reports, and investigator brochures
- Coordinate quality, editorial, and team document reviews
- Review statistical analysis plans and specifications for consistency
- Mentor less experienced writers on complex projects

Requirements:

- Minimum five years of lead regulatory writing experience
- Experience supporting Phase 2 and Phase 3 studies
- Lead writing experience with protocols and submissions
- Experience with clinical summaries and clinical study reports
- Experience with investigator brochures

Apply regulatory writing, clinical documentation, and review expertise to sponsor-dedicated medical writing at Syneos Health.

📌 Senior Regulatory Medical Writer (Canada)
🏢 Syneos Health
📍 Canada