Senior Medical Writer - Early Development Services
Core
Senior Medical Writer responsible for authoring clinical study reports, protocols, and regulatory documents (IBs, INDs, MAAs) to advance early-phase drug development programs.
Role type
Senior Medical Writer (Early Development)
Builds
Clinical and regulatory documentation for pharmaceutical/clinical trial programs
Domain
Pharmaceutical industry / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory writing, Clinical study reporting, Protocol development, Project management, Team leadership, Drug development process knowledge, Quality compliance, Program management
Preferred skills
Early phase clinical trial experience, Advanced degree in scientific discipline
Technologies
None stated
Responsibilities
Author routine clinical documents (CSRs, protocols), Assist with complex regulatory documents (IBs, INDs, MAAs), Ensure document quality and regulatory compliance, Assist with project timelines and budgets, Represent department at project and review meetings
Seniority
Senior, hands-on IC with leadership/mentorship responsibilities
