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Medical Writing Specialist

1 month ago

Maidenhead, Windsor and Maidenhead, United Kingdom LEE Fortrea Clinical Research Unit Limited Full time
Medical Writing Publisher Specialist, Europe

Fortrea Clinical Research Unit Limited is seeking a highly skilled Medical Writing Publisher Specialist to join our team in Europe. As a leading global contract research organization, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

Key Responsibilities:
  • Compile and publish high-complexity Phase II-IV clinical documents for regulatory submissions, including study protocols, CSRs, and IBs.
  • Ensure clinical documents are developed in accordance with appropriate style guides and requirements for international regulatory publishing.
  • Collaborate with globally diverse teams to manage compiling and publishing projects, setting priorities, and ensuring deadlines are accomplished.
  • Monitor study progress against plan, identify any significant variance, and recommend actions to implement if timelines are not on target.
Requirements:
  • Minimum 2 years of experience as a Publisher in a medical writing or clinical department, either in CRO, Pharma, or Biotech environments.
  • 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.
What We Offer:

At Fortrea Clinical Research Unit Limited, 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.

Our 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.