Regulatory Medical Writer

Location
Oxford
Salary
£40 - £65 per hour
Posted
19 Mar 2021
Closes
18 Apr 2021
Ref
50196
Contact
Hendre Moolman
Discipline
Medical Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
CK Group are recruiting for Regulatory Medical Writer to join a medical writing company in the pharmaceutical industry working remotely on an initial 6-12 month contract basis (outside IR35)

Regulatory Medical Writer Role:
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.

Your Background:
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.
  • Therapy experience in Oncology would be advantageous.

Apply:
For more information or to apply for this Regulatory Medical Writer position, please contact Hendre Moolman on 01438 842970 or email hmoolman@ckgroup.co.uk quoting job ref 50196.

It is essential that applicants hold entitlement to work in the UK.