Global Medical Affairs-Research Manager (m/f)

Description

• Oversee receipt and processing of study submissions by Global Medical Affairs - Research staff (GMA-R)
• Assist regions in the conduct of cross-functional research committee meetings used to review, approve and track studies
• Coordinate the capture, archiving and reporting of appropriate study level information (including patient safety information) from GMA run clinical trials
• Ensure coordination with pharmacovigilance and Regulatory Affairs to respond to external audits and requests from external regulatory bodies
• Assist and document fair-market value (FMV) assessments of approved studies in accordance with internal policies and procedures
• Oversee the tracking and communication of key outputs, performance metrics, and accomplishments related to GMA research studies
• Oversee the appropriate disclosure of study related information in accordance with compliance regulations
• Interface with key internal and external stakeholders to resolve study/project related issues and support the overall efficient and compliant functioning of the GMA-R program
• Plan and manage assigned Global Expanded Access/Named Patient Programs

• Master's degree required in a health sciences related field
• Profound research related experience and/or pharmaceutical industry experience, PhD desirable
• Proven track record of clinical study and project management and demonstrated ability to manage international cross-functional projects
• Demonstrated understanding of the legal and regulatory guidelines associated with pharmaceutical industry research and external granting functions and the ability to use knowledge to make sound operational decisions
• Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of internal and external clients
• Fluency in English