Principal Medical Writer sponsor dedicated

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Principal Medical Writer sponsor dedicated, Maidenhead

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Client:

MAI Fortrea Development Limited

Location:

Job Category:

-

EU work permit required:

Yes

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Job Reference:

d1dd66726bf1

Job Views:

8

Posted:

26.04.2025

Expiry Date:

10.06.2025

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Job Description:

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

Full time. Remote. UK, France, Spain or Portugal.

We are on a mission to deliver solutions that bring life-changing treatments to patients faster.

But we can't do it alone.

We are seeking an experienced Principal Medical Writer to lead the authoring and development of high-complexity clinical regulatory documents that are critical to our partner’s strategic projects.

This is why we need you.

Join Fortrea. Your job matters.

WHAT YOU WILL DO

You will work for one sponsor, embedded on their team. Under this framework, you will act as an:

You will serve as an expert contributor on our partner’s project teams. You will use your expertise to write, advise, and coordinate the development of complex clinical regulatory documents including Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, clinical summary modules, and overview documents in CTD/eCTD format for regulatory submissions worldwide.

Strategist

This role is ideal for Medical Writers passionate about leading the development of key documents that inform and align with project strategy.

You will be the nexus where multiple teams' expertise converge. You will leverage your experience to manage writing projects, coordinate with stakeholders, steer discussions, drive consensus, and facilitate decision-making to advance the document development cycle.

Requirements include an advanced degree (PhD or Masters), a minimum of 6 years of eCTD submission writing experience, including 3 years as a medical writing project lead. Proven experience in leading the development of clinical regulatory medical writing deliverables, especially efficacy or safety clinical summary modules and drug applications across regions, is essential.

This role demands visibility, proactivity, collaboration, excellent communication skills, and the ability to lead discussions, manage complex tasks, and engage stakeholders confidently. Integration within the partner’s team is crucial, requiring adaptability across environments and therapeutic areas.

A UNIQUELY DIVERSE CAREER

At Fortrea, your career path is yours to shape. We empower our team to steer their own development. Whether you thrive in medical writing or aspire to management, Fortrea offers support and training for leadership roles.

Your aspirations drive your journey with us.

Fortrea seeks motivated problem-solvers and creative thinkers passionate about overcoming barriers in clinical trials. Join us to revolutionize development processes and deliver therapies swiftly to patients in need. Embrace a collaborative workspace where personal growth and global impact go hand in hand.