Senior Medical Writer
$118k - $150k per yearAbCellera
AbCellera seeks a Senior Medical Writer to develop regulatory and clinical documents supporting antibody-based drug programs. The role requires extensive experience preparing nonclinical and clinical submissions, collaborating across functional teams, and maintaining expertise in evolving regulatory standards.
Responsibilities
- Prepare clinical and regulatory documents including Module 2-5, briefing books, safety updates, and agency responses
- Organize document review meetings and partner with project teams on authoring strategy
- Manage multiple concurrent projects while aligning deliverables and timelines across teams
- Build therapeutic area expertise and apply knowledge across development programs
- Lead adoption of AI-assisted writing tools to improve document preparation efficiency
Requirements
- 8+ years medical writing experience in pharma or biotech
- Relevant post-secondary degree
- Expertise writing clinical and regulatory documents per ICH, GCP guidelines
- Advanced knowledge of drug development, clinical research, and biostatistics
- Strong cross-functional collaboration and project management skills
- Experience with biologic therapy dossiers preferred
Compensation: CAD $118,000–$150,000 base annually
Vacancy posted 4 days ago
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