Medical Writing Publisher Specialist, Europe

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 a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

What if your medical writing publishing expertise was the only thing we need to accelerate new medicines approval?

Join Fortrea as our next Publisher in Medical Writing to drive the publishing of regulatory documents within a medical writing team embedded in one of the world s leading pharma companies.

This is a full-time , permanent and remote job based in Europe.

Ideal locations : UK, Spain, Germany and France .

WHAT YOU WILL DO

This is a critical position in our partnership with one of the world s most successful pharma companies, laser-focused on one thing : to accelerate medical innovations that improve their patients lives.

Working closely with globally diverse teams, you will be responsible for all components of compilation and publishing of high-complexity Phase II-IV clinical documents for regulatory submissions (Study protocols and protocol amendments, CSRs and CSR appendices, IB s, patient narratives, etc.)

The expertise you provide will ensure clinical documents are developed in accordance with appropriate style guides and requirements for international regulatory publishing.

This requires a methodical approach to regulatory submission standards, which includes :

• Electronic QC
• PDF bookmarking,
• Cross-references and internal / external hyperlinking,
• Margins and headers.

YOUR EXPERIENCE

Minimum 2 years as a Publisher in a medical writing or clinical department, either in CRO, Pharma or Biotech environments.

You have proven track record providing clinical document publishing expertise, organizing, formatting, and verifying submission-ready documents in eCTD format for EMA, FDA and MHRA.

• Master of Science or bachelor’s degree in a biomedical, life sciences, or related discipline.
• Advanced experience with MS Office, especially Word processing skills (macros, templates, etc.) as well as Adobe Acrobat / DXC.

PERSONAL / TEAM SKILLS

You ll be the nexus where multiple teams expertise converge . You will leverage your experience to manage compiling and publishing projects, setting priorities, and ensuring deadlines are accomplished. We ll trust you to :

• Closely monitor study progress against plan,
• Identify any significant variance and recommend actions to implement if timelines are not on target.

To drive publishing of this scale forward, this role requires visibility, proactivity, and excellent communication skills.

You must be comfortable navigating sudden change (of priorities and deadlines), managing complex regulatory documents, engaging with a variety of stakeholders, and confidently contributing your expertise based on experience.

Integration within the client s team is crucial, requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas.

A UNIQUELY DIVERSE CAREER

At Fortrea, we empower you to shape your own career path.

Whether you are passionate about the medical writing scientific side, or aspire to be in leadership roles, we provide comprehensive training, management support, a network of SME’s and KOL’s and opportunities to help you thrive.

Your aspirations drive your journey with us. Where do you see yourself?

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.

Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.

Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.