Lead regulatory medical writing for Syneos Health remotely from Canada, emphasizing protocols, protocol amendments, and accurate scientific communication. Partner closely with Clinical Scientists.

This sponsor-dedicated Senior Medical Writer role focuses on clinical study protocols and protocol amendments. You will manage writing activities across departments with minimal supervision while completing regulatory documents. The work requires explicit scientific presentation, organized reviews, and collaboration with clinical, statistical, regulatory, and medical affairs colleagues.

Key Responsibilities:

- Lead clear, accurate medical writing deliverables
- Manage study writing activities across departments
- Resolve client comments and coordinate document reviews




- Complete protocols, amendments, reports, and submission documents
- Apply ICH E3, templates, and regulatory standards

Requirements:

- Three to five years of relevant medical writing experience
- Experience with protocols and protocol amendments
- Ability to review statistical analysis plans
- Understanding of regulatory requirements and guidelines
- Willingness to travel less than twenty five percent

Use regulatory writing, protocol development, and scientific review expertise to deliver accurate clinical documents for Syneos Health.

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