A high profile, global role reporting into the Head Quarters of this far-reaching, global pharmaceutical company.This company are looking for two individuals to support the development projects and sales and marketing activities across the US, Japan and China. Reporting into the Global Head of Medical Affairs you will be responsible for providing up to date global medical and scientific advice to the Discovery, Development, Sales & Marketing and Business Development areas with in the business. In this highly autonomous role will have a large input into protocols, development plans and marketing support. Responsibilities will include:
- Design of clinical studies and responding to questions from authorities/ethics committees or investigators during clinical studies
- Contribute to clinical development programmes and overall product development plans
- Generating study documents (contribute to sections in Study Protocols, writing of text for IMPD, generate contributions to Investigator’s Brochure, review of Clinical Study reports).
- Generating documents for submissions in CTD format (INDs, NDAs, MAAs) and writing of expert reports for submission to authorities
- Participation in discussions on maintenance of marketed products and market expansion. This includes answering medical questions posed by authorities and generating documentation for e.g. type II variations
- Provide insight and direction to relevant medical issues and interact with Key Opinion Leaders
- Assist in review of in-licensing projects
- Advising discovery colleagues on new indications and targets, including discussing the requirements for future products
- Participating in the design of experimental studies (e.g. phase 0 studies)
You will be provided with all the training and support you need to help you to develop and progress in your career, but at the same time be given lots of responsibility and a real sense of ownership. If you are interested in finding out more about this rare opportunity please contact Ben Traies on 01438 743047, or email email@example.com who is the consultant leading these roles.