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Clinical Regulatory Medical Writer - Berkshire

Berkshire   •  Contract/Temporary, Full time

Hendre Moolman is recruiting for Clinical Regulatory Medical Writer to work with a Medical Writing company in the pharmaceutical industry at their site based in the Berkshire (M4/M40 corridor). This role is offered either full time or part time (around 3 to 4 days) on a 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 with remote working and office working on a full time or part time basis depending on 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 CL40969 in all correspondence.

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

  • Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
  • Posted: 11th January 2018
  • Expires: 8th February 2018
  • Reference: CL40969


  • Recruiter: Hendre Moolman
  • Phone: 01438 743 047