We like to consider you for this attractive position, if you have the following expertise:
You will be participating in planning, execution, and monitoring of drug metabolism and pharmacokinetic studies. Study planning, execution and coordination must comply to GLP, GCP, and the necessary regulatory requirements. You will, furthermore, prepare registration dossiers according to regulatory requirements, and write internal dossiers, publications, and presentations for scientific conferences. You hold a tight contact with the pharma industry, clinicians, and opinion leaders.
You have a scientific degree and a PhD in Medical, Pharmaceutical or Biological Sciences in connection with some practical experience in the investigative industry, drug development and drug approval, including the necessary regulatory requirements. Your expertise ranges from pharmacokinetics via planning, coordination, execution, and evaluating of pharmacokinetic studies, statistical analysis, to preparation of internal and registration dossiers, the latest on a national and international level. You are familiar with GLP, GCP, IND/CTX, NDA/MAA. Project management, strong spoken and written communication skill in German and English are also required.
You will be working in a highly motivated, friendly, international team which is looking for an independent, highly motivated, ambitious, success driven, goal-oriented person who could be a great team player, as well. In contrary to a big pharma company this company offers you dynamic and lean structures.