Senior Regulatory Medical Writer - Client Dedicated - Canada
Fortrea • montreal (administrative region), Canada
Role Description
At Fortrea, we help bring life‑changing treatments to patients faster. We are seeking an experienced Senior Regulatory Medical Writer to lead the development of high‑complexity clinical regulatory documents in partnership with a leading global pharmaceutical company.
What You Will Do
As a sponsor‑embedded Regulatory Medical Writer, you will lead the full development lifecycle of Phase II–IV clinical regulatory documents, with primary responsibility for:
- Clinical Protocols
- Investigator’s Brochure (IBs)
- Submissions
You will own document development from planning through final delivery, including:
- Leading kick‑off, communication, and comment‑resolution meetings
- Coordinating cross‑functional contributors and reviewers
- Maintaining alignment with sponsor goals, timelines, and milestones
- Interpreting clinical data and translating results into clear, compliant regulator...