Senior/Principal Medical Writer

  • Salary: £50,000 - £85,000
  • REF Number: 00050326
  • Consultant: Stephanie Maccioni
  • Contact: 01438 768713
  • Date Published: 23.04.2021
  • Sector: Non-Specific
  • Location: US/EU/UK Anywhere, Europe Anywhere, Home/Field Based, UK Anywhere, USA
  • Discipline: Medical Writing

CK Clinical are recruiting for a Senior/Principal Medical Writer to join a very successful, global consulting company. The role can be office based of full home based.

Senior/Principal Medical Writer Role:

  • 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.
  • 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.

Your Background:

  • Minimum of a BA/BS in Science. Advanced degree in a health-related science is desirable.
  • A PhD or MSc in Biology or health-related science is desirable and proven experience in pharmaceutical medical writing is preferred.
  • Familiarity with industry principles of drug safety, EU and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology.
  • Knowledge of ICH guidelines, drug regulation guidance, drug development processes
  • Excellent written and verbal skills.

Apply: For more information or to apply for this Senior/Principal Medical Writerposition, please contact Stephanie Maccioni on +44 (0)1438 768713 or email smaccioni@ckgroup.co.uk, quoting job ref 50326.

It is essential that applicants hold entitlement to work in the country where the services will be delivered.

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