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 quoting job ref 53857.

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

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