Medical Operation ManagerFull-timeWorkday Global Grade: 16Company DescriptionAbout AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.Job DescriptionMedical 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.QualificationsKEY 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 reportingTo be overall responsible for planning, implementation and communication of PMS in accordance with GPSP requirementManagement of Post Marketing Surveillances with on-site and off-site vendorsTo ensure planning and implementation of required GPSP training to relevant employees and others as appropriateTo implement corrective action if necessary after self-inspectionEducate GVP/GPSP knowledge to PMS members including on-site vendorsTo be familiar with GPSP and GCP guidelines and local regulatory regulationsRelated to PMS activity, act as Post-marketing surveillance manager for drugs and medical devicesManage projects of Medical Affairs initiated company sponsored studyIdentify and manage the vendors to conduct each studyManage and track Investigator initiated studies as based on request from HCPsClosely communicate with Medical Advisors and MSLs to plan and conduct the studies smoothlyClosely communicate with PV and PMQA representatives to support safety information related to aesthetics productsBudget Management & Analytics 10%Manage the vendors to maintain effective relationship in terms of cost and outcomesClosely working with Country Medical Director, track expenses against budget and reporting variations monthlyWork closely with other Medical Affairs functions to provide effective collaboration with global and vendersAllergan compliance policy 5%Ensure the related activities to study are compliant with AbbVie compliance policies and any regulation of study implementation global/locallyEducate the regulation to cross-functional counterparts5Professional and Personal Development: 5%Assess performance levels, identify root causes and develop action plans for continuous improvement for areas of responsibilityImplement the knowledge and skills gained in AbbVie training programs to work practice and follow upContinue 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 requiredTake responsibilities in company projects and adapt him/herself to the changing or new work conditions and requirementsAdditional InformationAbbVie 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.US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.htmlUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.htmlBy clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyI'm interestedI'm interestedPrivacy Notice
