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Clinical and Regulatory Medical Writing Manager

UK   •  Permanent, Full time


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:
Please quote reference 50260.

CLINGEN


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Jim Gleeson
  • Phone: 01438 743 047
  • Reference: 50260
  • Posted: 31st March 2021
  • Expires: 28th April 2021

CK Group

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