Senior Medical Writer

The role

You will prepare clinical and regulatory documents to support clinical development programs. This includes Module 2 to 5 documents, briefing books, safety updates, and responses to regulatory agencies.

What you will do

• Prepare clinical and regulatory documents including Module 2 to 5 documents, briefing books, safety updates, and responses to regulatory agencies
• Organize and conduct document review meetings
• Partner with project teams on authoring and content strategy
• Collaborate with team members to align on deliverables, writing processes, and timelines
• Stay current on US and international regulations and medical writing practices
• Lead the adoption of AI-assisted writing tools
• Build therapeutic area and product expertise

Required qualifications

• 8+ years of medical writing experience in pharma or biotech
• Relevant post secondary degree
• Strong oral and written communication skills
• Ability to oversee multiple projects simultaneously
• Extensive experience writing and editing clinical and regulatory documents following ICH guidelines, GCP, and other regulatory requirements
• Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology

Nice to have

• Experience preparing dossiers for biologic therapies

Benefits

• Equity
• Annual bonus dependent on team and company performance
• 6% (non-match) RRSP contribution
• CAD $1,500 annual Active Lifestyle Allowance
• Annual vacation
• Professional development opportunities
• Comprehensive health benefits
• Scientific and technical mentorship

Before you apply

• Refer to Job ID 23422 in your cover letter
• Only those selected for an interview will be contacted

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.