Principal Regulatory Medical Writer
Fortrea
full-time
Posted on:
Location Type: Remote
Location: Canada
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Job Level
About the role
- Lead the authoring and development of high‑complexity clinical regulatory documents
- Serve as a subject‑matter expert on global clinical and regulatory writing projects
- Lead the writing, review, and coordination of complex documents
- Drive development of key clinical documents that align with overall program and submission strategy
- Provide strategic input that shapes messaging, data presentation, and regulatory positioning
- Lead and manage complex medical writing projects across cross‑functional teams.
Requirements
- Bachelor’s degree in life science
- Advanced degree (PhD or Master’s) in a life science discipline preferred
- Minimum 6 years of eCTD submission medical writing experience
- 3+ years as a medical writing project lead
- Extensive experience leading development of clinical summaries (efficacy and/or safety) and regulatory submission documents across regions
- Proven ability to guide cross-functional stakeholders through complex submission development
- Deep understanding of global regulatory expectations and clinical development.
- Comfortable leading discussions, managing complex writing processes, influencing stakeholders, and contributing confidently based on experience.
Benefits
- Professionally development opportunities
- Health insurance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingeCTD submissionclinical summariesregulatory submission documentsclinical regulatory documentsdata presentationregulatory positioningproject managementcross-functional team leadershipstrategic input
Soft Skills
communicationinfluencing stakeholdersleading discussionsmanaging complex processesguiding stakeholderscollaborationproblem-solvingorganizational skillsadaptabilityconfidence