Medical Operation Manager
Core
Manage Post Marketing Surveillance (PMS) for drugs and medical devices, company-sponsored trials, and Investigator Initiated Studies (IIS) in alignment with Medical Advisors to develop Medical Aesthetics Strategy.
Role type
Senior Medical Operation Manager (GPSP)
Builds
Post-marketing surveillance programs and clinical studies for aesthetics products
Domain
Medical Devices & Pharmaceuticals (Aesthetics)
Required skills
Project management, vendor management, regulatory compliance (GPSP/GCP), budget management, safety information support, training delivery
Preferred skills
Knowledge of local regulatory regulations, experience with on-site and off-site vendor management
Technologies
None stated
Responsibilities
Conduct and manage PMS for drugs and medical devices including vendor control and reporting; Plan, implement, and communicate PMS in accordance with GPSP requirements; Manage projects of Medical Affairs initiated company sponsored studies; Identify and manage vendors to conduct each study; Manage and track Investigator initiated studies based on requests from HCPs; Communicate with PV and PMQA representatives to support safety information related to aesthetics products; Track expenses against budget and report variations monthly; Ensure related activities to studies are compliant with AbbVie compliance policies and regulations
Seniority
Senior, hands-on IC