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Senior Medical Writer

Senior Medical Writer

  • Location

    West Sussex, United Kingdom

  • Sector:

    Regulatory Affairs, Clinical Development

  • Job type:

    Permanent

  • Salary:

    £45,000 - £65,000 + Benefits

  • Contact:

    Andrew Robb

  • Job ref:

    36105

  • Published:

    almost 2 years ago

  • Expiry date:

    2019-03-21

Summary

My client, a niche CRO specialising in oncology is looking to take on their next senior medical writer. 

Responsibilities:

  • Investigational Medicinal Product Dossiers (IMPDs)
  • Clinical Trial Applications and amendments
  • Clinical study protocols and protocol amendments
  • Investigator brochures and updates
  • Interim and final clinical study reports (CSR) 
  • Development Safety Update Reports
  • Patient Informed Consent Forms
  • Scientific Advice Briefing documents
  • Provide guidance and support to other in-house units in preparation or review of manuals, training guidelines and similar documents

Minimum Requirements:

  • 2-3 years experience in a regulatory/PV/clinical writing environment 
  • Previous experience authoring or contributing to Clinical Trial Applications and Amendments, 
  • Excellent technical knowledge/understanding of regulatory affairs 
  • Bachelor’s degree required / Advanced degree preferred (PhD or MSc in Biology or health-related science is desirable)