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
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 in Ottawa employer: Syneos Health, Inc.
Syneos Health is an exceptional employer located in Winnipeg, Manitoba, offering a dynamic work culture that fosters collaboration and innovation. Employees benefit from diverse career paths, comprehensive training, and the opportunity to make a meaningful impact on patients' lives globally. With a commitment to inclusivity and professional growth, Syneos Health empowers its team members to thrive in a fast-paced environment while contributing to the advancement of biopharmaceutical therapies.
