Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) - Canada Remote Based
- Therapy areas
- Oncology, Hematology
- Writing types
- Regulatory
- Seniority
- Senior
About the role
Responsibilities
- Lead medical writing deliverables, ensuring scientific information is clear and accurate
- Write and review protocols, protocol amendments, clinical study reports and regulatory submissions
- Coordinate quality and editorial reviews and resolve client comments
- Partner with clinical scientists, biostatistics, regulatory affairs and medical affairs
- Mentor less experienced medical writers on complex projects
- Manage writing budgets and timelines
Requirements
- 3-5 years medical writing experience, including protocol writing
- Experience in biopharmaceutical, device or CRO industry
- Strong understanding of FDA and ICH regulations and good publication practices
- Experience with late development and oncology, hematology or cell therapy
- Experience with Veeva/CARA
- Strong English grammar and familiarity with AMA Manual of Style
About the Company
- Syneos Health is a fully-integrated life sciences services organization supporting drug development and commercialization.
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