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.

Role:

  • 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 jday@ckgroup.co.uk. Please quote reference 50260.

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