Job 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 regulatory documents

Who You Will Work With

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.

Your Experience

• Advanced degree in life sciences (Master’s or PhD) preferred.

• Minimum 4 years of regulatory medical writing experience

• At least 2 years as a medical writing project lead

• Strong expertise in CSRs and Protocols

Skills That Set You Apart

You are a confident project leader who thrives in complex, collaborative environments. You bring 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.

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.

• Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Regular and consistent attendance.

• Varied hours may be required.

Grow Your Career at Fortrea

At Fortrea, you can shape your career path - whether deepening your scientific expertise or pursuing leadership opportunities. We offer training, mentorship, and access to a global network of experts to support your growth.

Learn more about our EEO & Accommodations request here