Hannover-Braunschweig-Göttingen-Wolfsburg Region
Overarching operational management and coordination of development work in Cardior's portfolio projects concerning R&D and CMC activities, as well as associated regulatory procedures and interactions.
Project Manager and Consultant for product development primarily in the biotechnological and pharmaceutical industry.
Translational project management primarily in the biotechnological and pharmaceutical industry. Including planning and coordination in regard to non-clinical development, quality development, CMC, clinical development and regulatory interactions. Offering support in organizational and structural management for setting-up and supporting infrastructure for successful product development in companies, SPVs, and collaborations.
Responsible for the company’s internal QA system and support in the update process in regard to the new clinical trials - Regulation EU No 536/2014 and ICH E6(R2). Implementation of Risk based Quality Management approaches and ISO 9001:2008 in the company QA system.
Project leader of development projects (research, non clinical development, manufacture, regulatory, clinical development)