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Medical Writing Specialist

4 weeks ago

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

At LEE Fortrea Clinical Research Unit Limited, we are seeking a highly skilled Medical Writing Specialist to join our team in Europe.

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

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.

The successful candidate will be responsible for compiling and publishing high-complexity Phase II-IV clinical documents for regulatory submissions, ensuring that documents are developed in accordance with appropriate style guides and requirements for international regulatory publishing.

The ideal candidate will have advanced experience with MS Office, especially Word processing skills (macros, templates, etc.) as well as Adobe Acrobat/DXC.

We are looking for a motivated problem-solver and creative thinker who shares our passion for overcoming barriers in clinical trials.

As a Medical Writing Specialist, you will be responsible for:

  • Compiling and publishing clinical documents in eCTD format for EMA, FDA and MHRA.
  • Ensuring that documents are developed in accordance with appropriate style guides and requirements for international regulatory publishing.
  • Managing compiling and publishing projects, setting priorities, and ensuring deadlines are accomplished.

We offer a unique and diverse career path, with opportunities for growth and development.

At LEE Fortrea Clinical Research Unit Limited, we empower you to shape your own career path.

We are committed to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.