Clinical and Regulatory Medical Writing Manager
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.
- 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 email@example.com. Please quote reference 50260.