Principal Medical Writer
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
Principal Medical Writer works closely with stakeholders in Clinical Development, Clinical Operations, Biostatistics, and other functional areas and manages medical writing service providers to develop Regulatory documents, including but not limited to clinical study protocols and clinical protocol amendments, clinical study reports, patient narratives, clinical development plans, IND submissions, integrated summary reports, NDA/MAA and eCTD submissions, and Investigator Brochures, etc.
JOB FUNCTIONS/RESPONSIBILITIES
- Participate in and oversee vendors for the writing, editing, and confirmation of the scientific and medical accuracy of clinical and regulatory documents.
- Work collaboratively to incorporate/adjudicate comments from internal and external stakeholders
