Principal Strategic Medical Writer

Role: Principal Medical Writer leading the development of clinical and regulatory documentation for drug and/or device projects in biopharma. Responsibilities: independently preparing clinical/regulatory documents, coordinating reviews, ensuring quality, managing timelines, contributing to project strategies, and maintaining regulatory compliance across US and international standards. Qualifications: 5+ years in biopharmaceutical industry; Bachelor's degree or higher in a scientific discipline; expert knowledge of medical/scientific terminology; extensive experience in clinical/regulatory document writing/editing per ICH, GCP, and other guidelines; strong communication, data analysis, and project management skills. HighValue: experience with regulatory submissions, cross-functional collaboration, and familiarity with US and EU device regulations; ability to work independently and lead document processes. WorkSetup: not specified; based in a global pharma/biotech environment.