Director, Medical Writing

Role

Lead medical writing activities for global regulatory submissions within biopharma programs, ensuring accurate, compliant, and high-quality clinical documents.

oversee the development of regulatory documents such as IBs, CSRs, and marketing applications, coordinating internal teams and external resources, managing timelines, and maintaining adherence to global standards like ICH. Serve as a subject matter expert on document types, processes, and best practices; contribute to process improvements and SOPs; mentor or manage writers if applicable.

Bachelor's degree, 10+ years of medical writing experience in biopharma/CRO, deep understanding of clinical data interpretation, global regulatory requirements, and project management.

advanced degree in a scientific/clinical/regulatory field, therapeutic area expertise across all phases, and prior management experience.

extensive experience with global regulatory submissions, clinical development knowledge, and proficiency with electronic document management systems.

reports to a senior medical writing leader, possibly manages a team, participates in leadership and cross-functional initiatives.

not specified, but role involves global regulatory document oversight.