Medical Writing Specialist

2 weeks ago

Maidenhead, Windsor and Maidenhead, United Kingdom LEE Fortrea Clinical Research Unit Limited Full time

As a leading global contract research organization (CRO), LEE Fortrea Clinical Research Unit Limited 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.

Fortrea is seeking a highly skilled Medical Writing Specialist 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, with ideal locations in the UK, Spain, Germany, and France.

The successful candidate will be responsible for all components of compilation and publishing of high-complexity Phase II-IV clinical documents for regulatory submissions, including study protocols and protocol amendments, CSRs and CSR appendices, IBs, patient narratives, etc.

The expertise provided will ensure clinical documents are developed in accordance with appropriate style guides and requirements for international regulatory publishing, including electronic QC, PDF bookmarking, cross-references, and internal/external hyperlinking.

The ideal candidate will have a minimum of 2 years of experience as a Publisher in a medical writing or clinical department, either in CRO, Pharma, or Biotech environments, with a proven track record of providing clinical document publishing expertise.

They will also have advanced experience with MS Office, especially Word processing skills, as well as Adobe Acrobat/DXC.

The successful candidate will be the nexus where multiple teams' expertise converge, leveraging their experience to manage compiling and publishing projects, setting priorities, and ensuring deadlines are accomplished.

They will also be comfortable navigating sudden change, managing complex regulatory documents, engaging with a variety of stakeholders, and confidently contributing their 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.

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 SMEs and KOLs, and opportunities to help you thrive.

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.

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