Medical Writing Science Senior Manager (Hybrid)
Core
Independently authoring complex clinical study documents and regulatory submissions to support all phases of clinical drug development.
Role type
Senior Manager, Medical Writing Science
Builds
Clinical study protocols, clinical study reports, investigator's brochures, and sections of marketing authorization applications
Domain
Biotechnology / Clinical Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Authoring complex clinical regulatory documents, analyzing and summarizing highly complex data, understanding drug development and clinical research, project management, leading cross-functional teams
Preferred skills
Developing regulatory strategy, preparing advisory committee briefing documents, integrating new tools and technologies
Technologies
None stated
Responsibilities
Author complex clinical regulatory documents, serve as lead Medical Writing Scientist for pivotal studies, provide expert review of study-level documents, develop key messages for regulatory documents, provide leadership on regulatory strategy teams, contribute to content for regulatory agency meetings, ensure document compliance, contribute to process improvements
Seniority
Senior Manager, strategic leadership & cross-functional coordination
