Senior/Principal Medical Writer - US/EU/UK Anywhere

3 days left

CK Group
£50000 - £85000 per annum
23 Apr 2021
21 May 2021
Stephanie Maccioni
Contract Type
Full Time
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.

For more information or to apply for this Senior/Principal Medical Writerposition, please contact CK Group, 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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