Senior Regulatory Medical Writer

England  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.


Medical Records Medical Writing Study Protocols Regulatory Compliance Project Management


We are currently partnered with a global CRO, who are seeking a Senior Regulatory Writer to handle their complex regulatory 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 across various therapeutic areas.

If this role sounds like a great opportunity based on your skills and experience, then please do reach out!

I look forward to hearing from you!
Start date
EPM Scientific
Published at
Project ID:
Contract type
To apply to this project you must log in.