Director, Medical Writing

Position Summary

Director, Medical Writing works with Clinical Development, Clinical Operations, Biostatistics, and other teams and manages medical writing vendors to develop regulatory and clinical documents.

Job Functions/Responsibilities

• Oversee vendors for writing, editing, and scientific/medical accuracy of clinical and regulatory documents.
• Incorporate/adjudicate internal and external stakeholder comments to deliver high-quality final documents.
• Coordinate timely development, review, and publication with internal teams and external providers.
• Analyze complex data and collaborate on data analysis, description, and presentation.
• Coordinate development of protocols/amendments, clinical study reports, patient narratives, clinical development plans, IND, integrated summary reports, NDA/MAA and eCTD submissions, Investigator Brochures, and other assigned documents.
• Perform quality control and formatting finalization; support submission-level documents.
• Ensure adherence to timelines; manage multiple assignments in parallel.
• Prepare documents per Mirum SOP and applicable ICH/regulatory guidelines.
• Review SAP and Tables/Figures/Listings for CSR-ready data presentation; provide feedback.
• Communicate medical writing issues/solutions; advise project teams.
• Represent the department in audits and working groups.
• Maintain scientific/medical/technical knowledge and develop relationships with external advisors.

Qualifications

• Advanced degree; 8–10+ years medical writing experience (pharma/biotech/agency).
• Excellent writing/editorial and formatting skills; English fluency.
• Independently motivated, strong problem-solving; vendor management experience.
• Rare disease or liver disease background highly desirable.
• Knowledge of FDA/ICH; familiarity with AMA/Chicago style.
• Strong Word/Excel/PowerPoint; clinical research familiarity and ability to interpret/present complex data.
• Prioritization, multitasking, and on-time delivery.

Compensation

• Salary range: $230,000–$245,000 USD.