About this role
Mission Statement: The Senior Specialist of Evidence Generation, Evidence Solution, Medical Excellence and Operations. Medical is responsible for on-time study execution upon regulatory Post Marketing Observational Studies (reg-PMOS) and non-regulatory non-interventional studies. The Senior Specialist or Manager works as a study manager, the role involves study planning, study management and study quality management. Major Responsibilities: Work as a study manager according to the GPSP/GCP and SOP Co-development of Risk Management Plan with Pharmacovigilance Group and corresponding to PMDA Study protocol for reg-PMOS development and obtaining Abbvie Global Review committee’s approval Co-development of Study protocol for non-regulatory non-intentional studies with Medical Affairs. Study related material development Study planning (incl. feasibility, study budget, risk etc.), execution and management Management of CRO (monitoring, Data management & statistics) Essential Document archi...