Associate Director, Medical Writing
Proclinical is advertising a vacancy for an Associate Director for Medical Writing with a leading biopharmaceutical company. The organisation specialises in various therapy areas, including oncology, neuroscience, and rare disease fields. This is an exciting opportunity to work with an internationally renowned company and support their innovative impact on the healthcare field.
- As a compound lead, independently prepares, and at times directs the writing of protocols and amendments; independently prepares,
- Directs the writing for all sections of the CSRs
- Leads the preparation of clinical sections of submission documents, such as Module 2 summaries, briefing books, Global Investigator Brochures (GIB) and annual regulatory reports
- Liaises with other functional areas and groups in the development of document standards and structure
- Implements document quality controls, standards and best practices
Skills and Requirements
- Educated to Bachelor's degree in life sciences
- Experience in writing clinical study protocols, CSR's, and Module 2 clinical summaries
- Prior experience in oncology therapeutic area is desired.
- Excellent writing skills
- The medical writer should be familiar with ICH guidelines and the current AMA Style Manual.
- Maintain confidentiality, particularly related to employee personal information
- Excellent spoken and written English
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 Josh Godden on +44 203 854 0101 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.