Senior Medical Writing Manager
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.
- 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 firstname.lastname@example.org, quoting job ref 48676.
It is essential that applicants hold entitlement to work in the UK.