Senior Manager, Medical Writing
Proclinical is excited to announce a vacancy for a Senior Manager in Medical Writing to join a team in Hatfield. This is an amazing opportunity to combine your creativity and experience to a new role.
- As a lead writer, writes protocols and amendments, CSRs, global investigator brochures (GIB) and annual regulatory reports for assigned projects/programs.
- Leads 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
- Implements document quality controls, standards and best practices
- As needed, collaborates and provides guidance to other medical writers (eg, contractors) on team projects
Skills and Requirements
- Experience as a lead writer in preparing clinical study protocols, CSRs, Module 2 clinical summaries, investigator's brochures, briefing documents, as well as other regulatory and clinical documents
- Experience as a lead writer for a drug, leading the medical writing activities across a program
- Prior experience in the Oncology therapeutic area is desired.
- Excellent medical writing skills
- Meticulous attention to detail
- Proficiency using an electronic document management system
- Strong analytical ability to interpret clinical data
- Familiar with applicable ICH guidelines and medical writing style guidelines.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Oliver Jones on 02038541077 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.