Senior Manager, 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.
- 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 email@example.com, quoting job ref 48265.
It is essential that applicants hold entitlement to work in the UK.