Senior Regulatory Medical Writer
Job in
Mississauga, Ontario, C4W, Canada
Listed on 2026-10-28
Listing for:
Syneos Health, Inc.
Full Time
position Listed on 2026-10-28
Job specializations:
-
IT/Tech
Job Description & How to Apply Below
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 clear, 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
- 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.
Position Requirements
10+ Years
work experience
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