Clinical and Regulatory Medical Writing Manager

  • Salary: £60,000 - £75,000
  • REF Number: 00050260
  • Consultant: Julia Day
  • Contact: 07963 409838
  • Date Published: 31.03.2021
  • Sector: Immunology, Vaccines
  • Location: Remote / Home based, Oxon/Wilts
  • Discipline: Medical Writing

CK Clinical are recruiting for a clinical and regulatory writer to join a clinical stage pharmaceutical company who specialise in Immunotherapy and vaccines. This is the first in-house medical writing role for the company. It can be home based.


  • Provide preclinical subject matter expertise to support medical writing activities for product lifecycle management and regulatory submissions
  • Provide preclinical expertise to support to the development of nonclinical overviews and summaries to support registration renewals and new license applications.
  • Prepare clinical and regulatory documents
  • Independently prepare the writing of protocols and amendments and all sections of the clinical study reports
  • Lead the preparation of clinical sections of submission documents, briefing books, Investigator Brochures and annual regulatory reports.
  • Implement document quality controls, standards and best practices.

Your background:

  • Significant experience in the Pharmaceutical or biotechnology industries.
  • Significant experience in the preparation of key regulatory and clinical documents

Apply: Entitlement to work in the UK is essential. For more information or to apply for this Medical Writer position, please contact Julia Day on 01246 457719 or email Please quote reference 50260.


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