HEAD OF CLINICAL & MEDICAL AFFAIRS (M­­/­­F­­/­­X)

· Responsibility for the Clinical & Medical Affairs department, employee management and development · Definition/planning of clinical studies after the market launch nationally & internationally · Preparation of study contracts · Ensuring close communication and support for the study centers for an adequate study management · Analysis, evaluation and preparation of relevant clinical data / study results · Networking and collaboration with clinical study centers and KOLs · Preparation, review and approval of publications, congress presentations and marketing material · Participation in national & international exhibitions · Organization and implementation of wetlabs · Supporting market access procedures with the relevant bodies/authorities nationally & internationally · Responsibility for budget and time planning for the entire clinical strategy and its compliance, taking into account economic aspects and risks · Development, implementation and maintenance of Standard Operation Procedures (SOP) for clinical trials and clinical evaluation · Independent planning, preparation and maintenance of clinical documentation for regulatory purposes (e.g. Clinical Evaluation Plan and Report, clinical content for marketing authorization applications) · Supporting the clinical/regulatory affairs team worldwide with product registrations · Planning, control and responsibility of the department budget · Improvement & further development of clinical & medical affairs processes