Senior Medical Writer

We are looking for a skilled, detail-oriented Senior Medical Writer with extensive experience contributing to nonclinical, clinical, and regulatory affairs teams in a dynamic industry setting. You will be responsible for delivering high-impact regulatory documents that advance our programs and support our mission to bring new therapies to patients. If you are a writer who takes pride in turning complex science into clear, submission-ready documents, we'd love to hear from you. 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.

Responsibilities

Proactively preparing clinical and regulatory documents to support AbCellera's clinical development programs, including Module 2 to 5 documents, briefing books, safety updates, and responses to regulatory agencies; Organizing and conducting document review meetings, and partnering with project teams on authoring and content strategy; Collaborating with team members to align on deliverables, writing processes, and timelines; Staying current on US and international regulations and medical writing practices; Leading the adoption of AI-assisted writing tools to accelerate document preparation; Building therapeutic area and product expertise and applying it across development programs

Requirements

8+ years of medical writing experience in pharma or biotech; relevant post secondary degree; extensive experience writing and editing clinical and regulatory documents following guidelines and regulations such as ICH guidelines, GCP, and other regulatory requirements; ability to clearly communicate complex scientific and medical concepts to diverse audiences; deep command of domain terminology; strong oral and written communication skills; ability to oversee multiple projects simultaneously and collaborate cross-functionally; organization, time management, and problem-solving skills; 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; strong sense of community and connections across AbCellera through work, clubs, and socials