Medical Operation Manager

Medical Operation Manager role contributes to the project management of Medical Affairs studies includes Post Marketing Surveillance (PMS) for drugs and medical devices, Medical Affairs initiated company sponsored trial, Investigator initiated studies (IIS).
Medical Operation Manager role is the counterpart as local study manager to communicate with global counterpart and manage the vendors to conduct any studies in alignment with Medical Advisor to develop Medical Aesthetics Strategy.
Medical Operation Manager is also responsible as a GPSP role and communicate closely with PV and PMQA representatives to support safety information related to aesthetics products.
KEY DUTIES AND RESPONSIBILITIES:
Project Management of PMS and Medical Affairs studies 80%
Conduct and manage PMS for drugs and medical devices includes vendor control and reporting
To be overall responsible for planning, implementation and communication of PMS in accordance with GPSP requirement
Management of Post Marketing Surveillances with on-site and off-site vendors
To ensure planning and implementation of required GPSP training to relevant employees and others as appropriate
To implement corrective action if necessary after self-inspection
Educate GVP/GPSP knowledge to PMS members including on-site vendors
To be familiar with GPSP and GCP guidelines and local regulatory regulations
Related to PMS activity, act as Post-marketing surveillance manager for drugs and medical devices
Manage projects of Medical Affairs initiated company sponsored study
Identify and manage the vendors to conduct each study
Manage and track Investigator initiated studies as based on request from HCPs
Closely communicate with Medical Advisors and MSLs to plan and conduct the studies smoothly
Closely communicate with PV and PMQA representatives to support safety information related to aesthetics products
Budget Management & Analytics 10%
Manage the vendors to maintain effective relationship in terms of cost and outcomes
Closely working with Country Medical Director, track expenses against budget and reporting variations monthly
Work closely with other Medical Affairs functions to provide effective collaboration with global and venders
Allergan compliance policy 5%
Ensure the related activities to study are compliant with AbbVie compliance policies and any regulation of study implementation global/locally
Educate the regulation to cross-functional counterparts
5
Professional and Personal Development: 5%
Assess performance levels, identify root causes and develop action plans for continuous improvement for areas of responsibility
Implement the knowledge and skills gained in AbbVie training programs to work practice and follow up
Continue to develop and update product knowledge through reading textbooks, journal articles, and keep up to date with relevant scientific knowledge and participate and work in events including congress, symposia, field visits, training programs and be prepared to travel to the relevant location, where the function is required
Take responsibilities in company projects and adapt him/herself to the changing or new work conditions and requirements

Employment type
Full-time

Work arrangement
Hybrid