Senior Manager, Medical Writing

  • Salary: Competitive
  • REF Number: 00048265
  • Consultant: Robert Angrave
  • Contact: 01438 870022
  • Date Published: 22.05.2020
  • Sector: Oncology
  • Location: Hatfield, South East
  • Discipline: Medical Writing

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

The Senior Manager, Medical Writing Role:

  • Preparation of clinical and regulatory documents for the Oncology therapeutic area.
  • As a lead writer, writes 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 liaises 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 Manager, Medical Writing position, please contact Rob Angrave on 01438 870022 or email, quoting job ref 48265.

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

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