Principal Strategic Medical Writer
Core
Leading and writing clinical and regulatory documents for drug and device development to support company objectives.
Role type
Principal Strategic Medical Writer
Builds
Clinical and regulatory documentation for drug and device submissions
Domain
Biopharmaceuticals / Life Sciences
Required skills
Clinical and regulatory document authoring, US and international regulatory knowledge, therapeutic area expertise, project management, cross-functional collaboration, data analysis, scientific writing
Preferred skills
EU and US device writing experience, knowledge of ICH guidelines, GCP, CONSORT, PRISMA, drug development lifecycle, biostatistics, pharmacology
Technologies
ICH guidelines, GCP, CONSORT, PRISMA
Responsibilities
Prepare clinical and regulatory documents, coordinate review and quality control, communicate timelines and deliverables, lead process improvements, resolve writing process issues, draft responses to R&D Quality Assurance inquiries
Seniority
Principal, strategic leadership & hands-on execution
