Regulatory Medical Writer

  • Salary: £40.00-£65.00 per hour
  • REF Number: 00053857
  • Consultant: Hendre Moolman
  • Contact: 01438 842970
  • Date Published: 13.06.2022
  • Sector: Pharmaceutical, Clinical Research, Biotechnology
  • Location: Working from home, UK Anywhere
  • Discipline: Regulatory Affairs, Pharmacovigilance, Other

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 andregulatory 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 53857.

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

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