Senior Manager, Medical Writing
Core
Lead the development of clinical documents for drug development programs, ensuring compliance with regulations and Good Clinical Practices.
Role type
Senior Manager, Medical Writing
Builds
Clinical protocols, investigator brochures, clinical study reports, and integrated safety/efficacy summaries for drug development.
Domain
Biopharmaceuticals / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing, regulatory submissions (CTA/IND/NDA/BLA), eCTD formatting, Good Clinical Practices, FDA regulations, ICH guidelines, drug development process, project management, contract writer oversight, Microsoft Office suite
Preferred skills
Advanced degree, professional certification, experience in sponsor or CRO setting
Technologies
Microsoft Windows, Word, Excel, PowerPoint
Responsibilities
Produce high-quality clinical documents independently; manage review and finalization processes for internal and external documents; represent Medical Writing on project teams; collaborate with Biometrics, Clinical Operations, and Regulatory Affairs; contribute to SOP and template development.
Seniority
Senior, hands-on IC with management responsibilities
