About the role
Job Description
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.
Qualifications
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
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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