Freelance Senior Regulatory Medical Writer

England  ‐ Onsite
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Medical Records Medical Writing Study Protocols Biotechnology Clinical Works Immunology Project Management Safety Principles


We are currently partnered with a global biotechnology company, who are seeking an experienced regulatory writer to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions.

Key responsibilities:
  • Prepare, develop and finalise clinical documents for submission to regulatory authorities including briefing documents, IBs, study protocols, CSRs and CTDs.
  • Ensure these documents adhere to FDA/EMA or other regulatory guidelines and comply with clients SOPs.
  • Looks beyond existing methodologies and own discipline to define and resolve complex problems in areas critical to the achievement of objectives.

Requirements for the role:
  • Minimum experience of 6 years in preparing and writing clinical documents for submission to regulatory authorities.
  • Extensive writing experience in multiple clinical documents such as CSRs, CTDs, study protocols etc.
  • Good understanding of project planning, including identifying critical paths, time line requests, project resolutions etc.
  • Experience working in Immunology.

Contractual details:
  • 12 Months
  • Outside IR35 (If applicable)
  • 35-40 hours per week

If this opportunity sounds to be a great fit for you based on your skills and experience, then please do reach out!

*Please note that the desired freelancer can be based anywhere in Europe for this role*
Start date
12 Months
EPM Scientific
Published at
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