Principal Med Writer
Core
Lead medical and scientific writer responsible for planning, writing, and delivering complex clinical and regulatory documents to internal and external clients.
Role type
Principal Med Writer (Lead)
Builds
Clinical study reports, study protocols, Investigational Brochures (IBs), Investigational New Drug (IND) applications, and Marketing Authorization Applications (MAAs).
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
Medical and scientific writing, Clinical study report authoring, Study protocol development, Regulatory compliance, Therapeutic area expertise, Document review and editing, Process improvement, Budgeting and forecasting, Client presentation support
Preferred skills
Program management, Mentorship, Bid defense participation
Technologies
Document development software
Responsibilities
Research, write, and edit clinical study reports and study protocols; Serve as primary author for complex regulatory documents (IBs, INDs, MAAs); Provide senior-level review and training to junior writers and program managers; Ensure compliance with quality processes and regulatory requirements; Lead process improvement initiatives; Act as backup program manager for timelines, budgets, and contract modifications; Represent the department at project launch and review meetings.
