The Director, Medical Writing 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.
Responsible for leading the strategic development of clinical regulatory documents.
Prepare, edit, and finalize protocols, investigator brochures, synopses, clinical study reports, regulatory documents (INDs/NDAs, annual reports, Orphan Drug Designation applications, Agency Response to Questions, briefing books, etc.)
Collaborate with the clinical and scientific staff for narrative and data presentation planning, gather material for relevant documents and ensure that documents accurately reflect sources
Advanced Degree preferred
7+ years of hands-on regulatory writing experience
3+ years managing a team