Medical Writing Science Senior Manager (Hybrid)
Core
Independently author 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
Required skills
Clinical regulatory document authoring, complex data analysis, drug development lifecycle knowledge, regulatory requirements expertise, project management, cross-functional leadership
Preferred skills
Strategic scientific contributions, regulatory strategy definition, advisory committee briefing preparation
Technologies
Standard operating procedures, new tools and technologies integration
Responsibilities
Author complex clinical regulatory documents, 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 regulatory agency advisory committee presentations, ensure compliance with industry standards
Seniority
Senior Manager, hands-on IC with strategic oversight