Director, Medical Writing
$190,000–$230,000 year
Remote · Sioux Falls, South Dakota, United States
Job Summary
Director, Medical Writing for Biologics — provide strategic and operational leadership for the preparation, development, and delivery of regulatory documents (BLA/MAA/CSRs) supporting late-stage biologics and broader pipeline; lead ISS/ISE development for global submissions; drive submission readiness, cross-functional alignment across Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Pharmacovigilance, CMC, and leadership; ensure compliance with ICH, FDA, EMA guidelines; manage timelines, resources, and vendor relationships, and contribute to standards, templates, and process improvements; 10+ years medical writing experience and an advanced degree in Immunology or related discipline required; strong leadership, writing, and communication skills for complex regulatory narratives; travel as needed and home-office/remote-friendly environment.
Required Qualifications
- 10+ years of medical writing experience in biotech or pharmaceutical industry
- Advanced degree: PhD, PharmD, MD, MS in Immunology or related discipline
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