Global Medical Affairs Manager - Research (GMA-R) (m/f)

REFERENZNUMMER:

322065/1

IHRE AUFGABEN:

-Oversee receipt and processing of study submissions by Global Medical Affairs - Research staff (GMA-R)
-Assist regions with 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 Takeda 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

IHRE QUALIFIKATIONEN:

-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 clients both internal and external
-Fluency in English

WEITERE QUALIFIKATIONEN:

Medical affairs manager