Principal Regulatory Medical Writer Client Dedicated Canada
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Job Location:
Monthly Salary:
Posted on:
23 hours ago
Vacancies:
1 Vacancy
Job Summary
At Fortrea we are driven by a single mission: to bring lifechanging treatments to patients faster.
To achieve this we are seeking an experienced Principal Regulatory Medical Writer to lead the authoring and development of highcomplexity clinical regulatory 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 sponsordedicated Principal Regulatory Medical Writer you will operate as a core member of the clients portfoliolevel teams acting as an expert contributor strategist and project leader.
Expert Contributor
Serve as a subjectmatter 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
Investigators 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 crossfunctional teams
Coordinate stakeholders facilitate discussions drive consensus and support timely decisionmaking throughout the document lifecycle
What You Bring
Bachelors degree in life science.
Advanced degree (PhD or Masters) 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 crossfunctional 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 clients 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 handson with science and working closely with highprofile 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.
Required Experience:
Staff IC
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
