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Regulatory Medical Writer

UK   •  Contract/Temporary, Full time


Hendre Moolman is recruiting for Regulatory Medical Writer to join a medical writing company in the pharmaceutical industry at their site based in Oxford or working remotely on a permanent or contract basis.

The main purpose of the role will be to:
- Write clear, concise regulatory documentation.
- As a specialist writer, ensure smooth progress from submission to approval as you are involved in authoring various regulatory documents.
- Work on core dossier preparation and regulatory responses.

Further responsibilities will include:
- Writing integrated safety and efficacy summaries.
- Authoring clinical study reports (Phase I - IV) and Clinical Evaluation Reports (CERs).
- Composing non-clinical reports and briefing documents.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Life Science degree or higher qualification (MSc, or PhD).
- Proven experience authoring the majority of Regulatory documents (CTDs, NDAs, MAAs, CERs, CSRs).
- Experience in quality checking material.

This is an excellent opportunity to join a dynamic company with a flexible working set up.

Benefits include a competitive rate, and working remotely or in the office on a full time or part time basis depending company requirement.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.  Please quote reference 46220 in all correspondence.


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Hendre Moolman
  • Phone: 01438 743 047
  • Reference: 46220
  • Posted: 8th August 2019
  • Expires: 5th September 2019

CK Group

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