Medical Expert Aachen, Germany
Since July 2015
Associate Director Medical Affairs Aachen, Germany
September 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, 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.
* Presentations at international investigator and medical affairs meetings.
* Generation of clinical trial reports (document owner) and author of scientific publications.
* 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