Senior Medical Writing Manager

  • Salary: Competitive
  • REF Number: 00048676
  • Consultant: Hendre Moolman
  • Contact: 01438 842970
  • Date Published: 10.08.2020
  • Sector:
  • Location: Hatfield,
  • Discipline:

CK Clinical are recruiting for a Senior Medical Writing Manager for a well-established pharmaceutical company based in Hatfield, UK until March 2021.

Senior Medical Writing Manager Role: Your main duties will be to:

  • Prepare clinical and regulatory documents for the Oncology therapeutic area.
  • As a lead writer, write protocols and amendments, CSRs, global investigator brochures (GIB) and annual regulatory reports for assigned projects/programs.
  • Lead the preparation of clinical documents for submissions, such as Module 2 summaries, briefing books, and response documents.
  • Independently liaise with other functional areas and groups in the preparation of assigned documents.
  • Implement document quality controls, standards and best practices.
  • As needed, collaborates and provides guidance to other medical writers (e.g. contractors) on team projects.

Your Background:

  • Experience in writing clinical study protocols, CSR's, and Module 2 clinical summaries.
  • Prior experience in oncology therapeutic area is desired.
  • Excellent writing skills.
  • Meticulous attention to detail.
  • Proficiency using an electronic document management system.
  • Strong analytical ability to interpret clinical data.
  • The medical writer should be familiar with ICH guidelines and the current AMA Style Manual.

Apply: For more information or to apply for this Senior Medical Writing Manager position, please contact Hendre Moolman on 01438 842 970 or email hmoolman@ckclinical.co.uk, quoting job ref 48676.

It is essential that applicants hold entitlement to work in the UK.

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