Job summary
Seeking a Senior or Principal Medical Writer specializing in regulatory documentation to lead the development and completion of clinical study-related documents. The role involves coordinating writing efforts across departments and managing client feedback, ensuring compliance with regulatory standards. Remote role open to candidates in the US and Canada, focusing on clinical phases 2 and 3 studies.
Location and work setup
- Location
- Norway
- Work setup
- Remote
Salary
USD 80600.00–175700.00 year
Responsibilities
Lead the creation and review of regulatory medical writing deliverables, including protocols, clinical study reports, investigator brochures, patient narratives, periodic safety update reports, and submission documents. Coordinate with cross-functional teams to ensure timely delivery within budget, maintain compliance with regulatory standards such as ICH E3 guidelines, and lead resolution of client comments. Provide mentorship to junior writers, perform literature searches, manage document quality and editorial reviews, and support process improvements. Minimal travel may be required.
Qualifications
Minimum of 5 years experience leading regulatory writing projects, with demonstrated expertise in Phase 2 and 3 clinical study documentation. Proven background authoring protocols, clinical study reports, safety summaries, investigator brochures, patient narratives, and regulatory submission documents (IND, NDA, eCTD). Strong project and time management skills and experience working with clients in a regulatory writing capacity. Ability to work independently in remote settings across US and Canada is required.