Principal Medical Writer
$201,000–$251,000 year
Remote
Job Summary
Draft and manage content and reviews for clinical regulatory documents including protocols, IBs, CSRs, briefing documents, periodic safety reports, risk management documents, and IND/NDA modules. Serve as the primary medical writing contact for clinical development programs, representing the team in cross-functional planning meetings and scheduling document reviews. Develop and maintain document templates, standard processes, work instructions, onboarding materials, and style guides while mentoring junior and contract writers. Independently resolve document content issues, hold team members accountable to project dates, and recognize scheduling conflicts to provide resolution recommendations. Ensure consistency, clarity, and accuracy across all deliverables while managing competing deadlines in a high-pressure environment.
Required Qualifications
- 8-11 years of clinical regulatory writing experience within one or more biopharmaceutical companies
- prior experience working as a medical writer for a BLA/NDA/MAA
- Advanced degree in clinical or life sciences, English, journalism, and/or communications
- Proficiency in Microsoft Word, including the use of MS Word styles and templates
- Familiarity with AMA style
- Ability to successfully manage and prioritize writing projects with competing deadlines
- Ability to foster collaborative cross-functional relationships
- Ability to drive high-quality regulatory writing projects to successful submission
- Ability to work in a high-pressure environment with short deadlines
- Ability to remain calm, focused, professional, diplomatic, and positive
Desired Qualifications
- Experience with oncology therapeutics
- Familiarity with StartingPoint
- Familiarity with EndNote
- Familiarity with Veeva RIM
- Familiarity with Smartsheet
- Experience performing QC reviews of clinical regulatory documents
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