Manager, Content Strategy and Development (Medical Writing)- Oncology
Core
Prepare clinical documentation for global regulatory submissions in oncology, including clinical study reports, protocols, and investigator brochures.
Role type
Manager, Medical Writer (Oncology)
Builds
Clinical/regulatory documents for regulatory submissions
Domain
Biopharmaceuticals / Oncology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical research and development experience, Regulatory affairs experience, Medical writing in clinical submissions environment, Knowledge of regulatory document requirements/guidelines, Document management systems proficiency, Cross-functional team collaboration
Preferred skills
None stated
Technologies
Microsoft Office, Document management systems
Responsibilities
Author clinical study reports, protocols, amendments, and investigator brochures; Collaborate with senior writers on integrated clinical summaries and pediatric investigation plans; Participate in regulatory submission teams to guide data presentation; Manage document timeline and resource planning; Develop document standards, templates, and processes
Seniority
Manager, hands-on IC
