Senior Regulatory Medical Writer - Client Dedicated - Canada
About The Position
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. 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), 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.
Requirements
- Minimum 4 years of regulatory medical writing experience
- At least 2 years as a medical writing project lead
- Strong expertise in CSRs and Protocols
- Confident project leader who thrives in complex, collaborative environments.
- Strong communication skills, proactive leadership, and the ability to drive consensus while managing multiple stakeholders and priorities.
- Flexibility and seamless integration into the sponsor’s team are essential.
Nice To Haves
- Advanced degree in life sciences (Master’s or PhD) preferred.
Responsibilities
- Lead the full development lifecycle of Phase II–IV clinical regulatory documents.
- Primary responsibility for Clinical Protocols, Investigator’s Brochure (IBs), and Submissions.
- Own document development from planning through final delivery.
- Lead kick-off, communication, and comment-resolution meetings.
- Coordinate cross-functional contributors and reviewers.
- Maintain alignment with sponsor goals, timelines, and milestones.
- Interpret clinical data and translate results into clear, compliant regulatory documents.
Benefits
- Training
- Mentorship
- Access to a global network of experts
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
