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Regulatory Medical Writing Manager

Central London   •  Negotiable  •  Permanent, Full time

Regulatory, Medical Writing Manager

Location - UK, Italy, Spain, Netherlands, Poland, France, and Germany

(Fully Remote)

Medical Writing Manager opportunity working for a leading global clinical research organisation that works with a number of top 5 pharmaceutical companies, and growing biotechs.

As a Lead Medical Writer, you will manage and support all Regulatory and Clinical writing for a number of exciting projects. You will be responsible for the preparation of clinical regulatory documentation for regulatory submissions, writing clinical documents e.g. IBs, CSRs, clinical overviews, module 2 clinical summaries, paediatric plans, orphan designation applications, and regulatory briefing documents.

The role will be supporting junior medical writers by reviewing the documentation including offering training and support. As a Medical Writing Manager, you will sit within a large and interactive team of other regulatory writers and support a number of innovative projects.


• Initial Investigational New Drug (IND) applications and amendments

• Clinical study protocols and protocol amendments

• Investigator's brochures and updates

• Interim and final clinical study reports

• IND annual reports

• Development safety update reports


• Multiple years working in a medical writing position. 5+ years prior experience in a CRO/pharmaceutical environment

• Supported junior team members, with reviewing documents and provided training and mentoring

• Experience working as the lead writer on multiple regulatory and clinical documentation

• Bachelor’s degree required / Advanced degree preferred

This is an excellent opportunity to gain further exposure in Medical Writing, acting as a senior figure within a leading business. This role can be a fully remote position across Europe and comes with an attractive package and a number of career development opportunities.

If you are interested in this role or would like more details please email your CV to lucy.kirkaldy@cpl.com

Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.

  • Agency: Cpl Life Sciences
  • Reference: JO-2305-516913
  • Posted: 26th May 2023
  • Expires: 23rd June 2023

Cpl Life Sciences

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