Associate Director, Medical Writing

  • Salary: Competitive
  • REF Number: 00046796
  • Consultant: Robert Angrave
  • Contact: 01438 870022
  • Date Published: 22.05.2020
  • Sector: Oncology
  • Location: Hatfield, South East, Home Counties
  • Discipline: Medical Writing

CK Clinical are recruiting for an Associate Director of Medical Writing for a well-established pharmaceutical company based in Hatfield, UK.

The Associate Director of Medical Writing Role:

  • Preparation of clinical and regulatory documents for the Oncology therapeutic area.
  • As a compound lead, independently prepares, and at times directs the writing of protocols and amendments; independently prepares, and at times directs the writing, all sections of the CSRs.
  • Lead the preparation of clinical sections of submission documents, such as Module 2 summaries, briefing books, Global Investigator Brochures (GIB) and annual regulatory reports.
  • Liaise with other functional areas and groups in the development of document standards and structure.
  • Implement document quality controls, standards and best practices.

Your Background: Qualifications and Education required:

  • Educated to Bachelor's degree in Life Sciences.
  • RN, Master's degree in Life Sciences, PharmD or PhD preferred.
  • Demonstrated experience writing clinical and regulatory documents in the pharma industry.

Experience required:

  • 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.

Skills and Aptitude required:

  • Strong interpersonal skills with an ability to communicate across different levels.
  • Diplomacy and rationale in difficult situations.
  • Ability to handle many tasks and setting shifting and competing priorities.
  • Ability to direct the work of others and acts as a coach and mentor to staff members.
  • Excellent project management skills related to medical writing documents.
  • Creative and analytical in approach.
  • Attention to detail and accuracy.
  • Excellent spoken and written English.
  • Maintain confidentiality, particularly related to employee personal information.

Apply: For more information or to apply for this Associate Director of Medical Writing position, please contact Rob Angrave on 01438 870022 or email rangrave@ckclinical.co.uk, quoting job ref 46796.

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

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