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 archiving