Principal Medical Writer
ProPharma Group · US
Medical AffairsFull-timeCompany career page
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Role summary
ProPharma Group seeks a Principal Medical Writer to lead the development of clinical and regulatory documents across the product lifecycle. The role involves managing complex deliverables, supervising junior writers, and collaborating with cross-functional teams to support biotech, pharmaceutical, and medical device clients.
What they're looking for
- Bachelor's degree or higher, preferably in medical or scientific discipline
- Minimum 7 years clinical and regulatory document writing experience in pharma, biotech, or CRO
- Advanced knowledge of FDA regulations, ICH guidelines, and submission requirements
- Expert proficiency with MS Word, including tables, graphs, and figure management
- Strong project management and client relationship building capabilities
- Advanced ability to interpret clinical data and complex scientific information
- Proficiency in English and familiarity with AMA style
What you'll be doing
- Author and edit high-quality clinical, regulatory, and safety documents across therapeutic areas and development phases
- Manage clinical program deliverables including protocols, study reports, IBs, ICFs, and submission-level documents
- Supervise, train, and mentor less experienced medical writers as needed
- Independently manage client expectations, lead project meetings, and coordinate cross-functional resources
- Perform quality control reviews, peer reviews, and coordinate audit trails for document changes
Privacy & handoff
This role links to ProPharma Group's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.