Director, Medical Writing
Mirum Pharmaceuticals, Inc.
August 16, 2026
Remote friendly (Foster City, CA)
United States
Clinical Research and Development
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.
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.