Medical Writer (PhD)
Core
Producing regulatory documents (IND, NDA) and clinical study reports/protocols for drug and medical device development.
Role type
Senior Medical Writer (PhD)
Builds
Regulatory submissions and clinical study documentation for pharmaceutical and medical device clients.
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
Regulatory document writing, Clinical study reporting, Protocol development, Quality control review, Project management, Computer skills
Preferred skills
Life science PhD, Attention to detail
Responsibilities
Write IND modules, NDA modules, clinical study reports, protocols, and protocol amendments; Coordinate quality control reviews and maintain audit trails; Interact with sponsors and subject matter experts.
