1) Responsible for providing medical and scientific expertise for the support of EPD products including regulatory and safety documents; advertising and promotional review; and global medical information.
2) Serves as a conduit and facilitator of communication between Medical Affairs and Commercial, Global PV, Global Regulatory, and affiliate medical departments with respect to assigned brands.
3) Provides training to affiliates and other colleagues on medical information and medical review skills to support their business objectives.
1) Minimum of 4 years of combined licensed clinical practice experience, postgraduate training, and/or postgraduate pharmaceutical industry experience.
2) Strong clinical reasoning skills, with the ability to independently assess and conclude on published and in-house data related to pharmaceutical products and EPDs therapeutic areas
3) Needs to be able to think strategically and demonstrate ability to make effective decisions based on good science and data in compliance with regulatory requirements; can comfortably handle risk assessment and uncertainty.
4) Basic knowledge of industry trends and processes, clinical data, statistical concepts, and regulatory requirements to provide scientific and clinical support of pharmaceutical products.
5) Strong writing skills are required.
6) Successful project management experience required.