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, quoting job ref 48676.

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

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