Senior Regulatory Medical Writer Client Dedicated Canada

Toronto - Canada

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

At Fortrea we help bring lifechanging treatments to patients faster. We are seeking an experienced Senior Regulatory Medical Writer to lead the development of highcomplexity clinical regulatory documents in partnership with a leading global pharmaceutical company.

What You Will Do

As a sponsorembedded Regulatory Medical Writer you will lead the full development lifecycle of Phase IIIV clinical regulatory documents with primary responsibility for:

Clinical Protocols
Investigators Brochure (IBs)
Submissions

You will own document development from planning through final delivery including:

Leading kickoff communication and commentresolution meetings
Coordinating crossfunctional 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 crossfunctional teams including Biostatistics Data Management Programming Clinical Leadership Project Physicians and Medical Writing colleagues across Canada Europe the Americas and AsiaPacific.

Your Experience

Bachelors degree in life science.
Advanced degree in life sciences (Masters 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 sponsors 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.

Required Experience:

Senior IC

At Fortrea we help bring lifechanging treatments to patients faster. We are seeking an experienced Senior Regulatory Medical Writer to lead the development of highcomplexity clinical regulatory documents in partnership with a leading global pharmaceutical company.What You Will DoAs a sponsorembedded...