Scientific Writer II
Core
Coordinate and author regulatory documents (Investigator's Brochures, safety reports, clinical study reports, protocols) for pharmaceutical drug development, integrating scientific, medical, and regulatory input.
Role type
Senior regulatory scientific writer
Builds
Regulatory documentation for global pharmaceutical drug development
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory documentation authoring, complex data analysis, global drug development knowledge, timeline management, cross-functional collaboration, document management systems
Preferred skills
None stated
Technologies
Document management systems
Responsibilities
Coordinate and author regulatory documents; Manage timelines for document components; Participate in document strategy sessions; Maintain document prototypes; Resolve issues to ensure quality; Review and edit documents
Seniority
Mid-level (2-4 years experience)
