Medical ExpertAachen, Germany
Since July 2015
Associate Director Medical Affairs Aachen, GermanySeptember 2009 --- June 2015
main responsibilities included the coordination (project lead) of international medical affairs initiated phase iiib/iv Clinical trials, including:
* cooperation with all involved departments such as Clinical operations, Drug Safety, Project Management, science, Regulatory Affairs, Data Management, statistic, and grünenthal affiliates as well as external service provider.
* tracking of the overall phase iiib/iv budget.
* generation of trial specific documents such as protocols, science)" rel="nofollow">Protocol amendments, master Informed Consent forms etc. as well as generation and/ or review of further trial documents.
* provision of ec and ra responses and continuous medical support throughout the trials.
* management of involved kols.
* set-up and coordination of international compassionate use/named patient program processes.
further responsibilities include but are not limited to:
* review of clinical parts of Reimbursement and submission dossiers.
* review of Publications and posters.
* development of Training materials and providing internal product trainings.
* involvement in the development of Communication strategies.
* contribution to international congresses (e.g. symposia, poster Presentations) and advisory
CollaborationProblem solvingResponsibilityService orientedSociabilityStrategic thinkingResult OrientedFlexibility