Principal Medical Writer

Role: Director of Medical Writing at Mirum Pharmaceuticals, focusing on developing regulatory documents for rare disease programs. Responsibilities include managing internal teams and vendors to produce clinical study protocols, reports, IND/NDA submissions, and other regulatory materials, ensuring scientific accuracy, quality, and adherence to timelines. Key tasks involve collaboration with clinical, biostatistics, and regulatory teams, analyzing complex data, and maintaining high standards in document preparation. Qualifications: 8-10 years of medical writing experience within pharma/biotech, with strong editorial skills, and proficiency in FDA/ICH guidelines, with a preference for candidates with rare or liver disease backgrounds. Skills: deep scientific knowledge, vendor management experience, excellent communication, and advanced proficiency in MS Office. High-value specifics: focus on rare diseases, extensive regulatory document development, and a senior leadership role overseeing compliance and quality. Work setup: not specified, but likely collaborative and fast-paced given the nature of the role.