At Fortrea, we are driven by a single mission: to bring life‑changing treatments to patients faster .

To achieve this, we are seeking an experienced Principal Medical Writer to lead the authoring and development of high‑complexity clinical regulatory documents. In this role, you will be fully dedicated to a key strategic client , a Top 10 global pharmaceutical company, and embedded within their team.

This is meaningful work with real impact. Your job matters at Fortrea. What You Will Do As a sponsor‑dedicated Principal Medical Writer, you will operate as a core member of the client’s portfolio‑level teams, acting as an expert contributor, strategist, and project leader.

Expert Contributor

• Serve as a subject‑matter expert on global clinical and regulatory writing projects

• Lead the writing, review, and coordination of complex documents, including:

• CTD Modules 2.73 (Clinical Efficacy) and 2.74 (Clinical Safety)

• Clinical Study Protocols

• Clinical Study Reports

• Investigator’s Brochures

• Integrated CTD/eCTD submission content for worldwide regulatory filings

Strategist

• Drive development of key clinical documents that align with overall program and submission strategy
• Provide strategic input that shapes messaging, data presentation, and regulatory positioning

Project Leader

• Lead and manage complex medical writing projects across cross‑functional teams
• Coordinate stakeholders, facilitate discussions, drive consensus, and support timely decision‑making throughout the document lifecycle

What You Bring

• Bachelor’s degree in life science.
• Advanced degree (PhD or Master’s) in a life science discipline preferred.
• Minimum 6 years of eCTD submission medical writing experience, including 3+ years as a medical writing project lead
• Extensive experience leading development of clinical summaries (efficacy and/or safety) and regulatory submission documents across regions
• Proven ability to guide cross‑functional stakeholders through complex submission development
• Deep understanding of global regulatory expectations and clinical development

Leadership & Collaboration Success in this role requires strong visibility, initiative, and collaboration. You are comfortable leading discussions, managing complex writing processes, influencing stakeholders, and contributing confidently based on experience.

You will integrate seamlessly into the client’s organization, demonstrating adaptability across therapeutic areas and readiness to take on expanded responsibilities.

At Fortrea, you shape your career .

• If you are passionate about remaining hands‑on with science and working closely with high‑profile clients, we support deep technical expertise.
• If you are interested in moving toward people or functional leadership, we offer training and development to help you get there.

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.

Learn more about our EEO & Accommodations request here.