Principal Medical Writer
IQVIA · Durham, NC
Medical AffairsFull-time$84k–$211kCompany career page
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Role summary
IQVIA seeks an experienced Principal Medical Writer to lead development of clinical and regulatory documents for global submissions. The role involves directing medical writing activities across multiple programs, providing strategic guidance to cross-functional teams, and ensuring compliance with international regulatory standards.
What they're looking for
- Bachelor's degree in scientific, clinical, regulatory, or related field; advanced degree preferred
- 7+ years medical writing experience in biopharmaceutical, biotechnology, or CRO settings
- Deep knowledge of global regulatory requirements (ICH, FDA, EMA) across clinical development phases
- Strong understanding of clinical research processes, study design, and regulatory submissions
- Demonstrated leadership ability for complex document development and cross-functional collaboration
- Excellent written and verbal communication skills for complex scientific information
- Strong project management, organizational skills, and ability to manage multiple priorities
What you'll be doing
- Lead development of clinical and regulatory documents including IBs, CSRs, and marketing authorization submissions
- Oversee medical writing activities across multiple compounds and provide strategic guidance to teams
- Manage medical writing projects including planning, timelines, resource coordination, and deadline delivery
- Mentor other medical writers and ensure scientifically sound, consistent deliverables across projects
- Develop and refine SOPs, templates, and best practices while staying current with regulatory requirements
Privacy & handoff
This role links to IQVIA'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.