Senior Medical Writer - Early Development Services
Core
Senior Medical Writer creating clinical study reports, protocols, and regulatory documents (IBs, INDs, MAAs) for early-phase drug development programs.
Role type
Senior Medical Writer (Early Development)
Builds
Clinical and regulatory documents for pharmaceutical/CRO clients
Domain
Pharmaceutical industry, Clinical Research, Regulatory Affairs
Required skills
Regulatory writing, Clinical study reporting, Protocol writing, Project management, Team leadership, Drug development process knowledge, Quality compliance
Preferred skills
Early phase experience, Advanced degree
Technologies
None stated
Responsibilities
Author routine documents (clinical study reports, protocols), Assist with complex documents (IBs, INDs, MAAs), Ensure document quality compliance, Assist with program management (timelines, budgets), Represent department at project meetings
Seniority
Senior, hands-on IC with leadership/mentorship duties
