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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 Brochures (IBs), and 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, and interpreting clinical data and translating results into clear, compliant regulatory documents.
You will collaborate with global, cross‑functional teams including Biostatistics, Data Management, Programming, Clinical Leadership, Project Physicians, and Medical Writing colleagues across Canada, Europe, the Americas, and Asia‑Pacific.