Principal Medical Writer - FSP (M/W/D)
Core
Develop clinical documents for global regulatory submissions and provide strategic direction to cross-functional teams to ensure accurate, scientifically rigorous data presentation.
Role type
Principal Medical Writer (Regulatory)
Builds
Regulatory documents (IBs, CSRs, marketing authorization submissions)
Domain
Biopharmaceuticals / Clinical Research / Regulatory Affairs
Required skills
Medical writing, regulatory document development, project management, cross-functional team leadership, SOP creation, contract resource management
Preferred skills
Advanced degree in scientific/clinical/regulatory field, therapeutic area knowledge, global regulatory requirements expertise
Technologies
ICH guidelines, global regulatory standards
Responsibilities
Develop regulatory documents for global submission, manage medical writing projects and timelines, review associated documents (Protocols, SAPs), define and write SOPs, manage internal and contract writing resources
Seniority
Principal, strategic direction with minimal oversight