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Senior Associate Regulatory Labeling Thousand Oaks United States,  

Posted on : 01 May 2017

Project Description

As part of Global Labeling (GL), reporting to the Labeling Performance, Sr Manager, the Labeling Performance, Sr Associate is responsible for supporting the monitoring and reporting on the health of the end to end labeling process through Quality System Managements, supporting continuous improvement projects, triaging BPM tool issues and enhancements to BPM owner and certification content development for Global Labeling roles.The purpose of the Global Labeling (GL) group is to develop and maintain core labeling documents to provide quality product labels and to drive global labeling strategy to ensure safe and effective use of Amgen products for patients and healthcare providers around the world.Principal Responsibilities:Reporting and tracking deviations and waivers timeline adherenceCreate performance and metrics reports for Labeling KPI sAnalyze issuesSupport Quality System Management process: Support CAPAs for Global Labeling organization and vendorsSupport the maintenance of global labeling SOPs and manualSupport Global Labeling Training Assignment and OnboardingTriage BPM tool issues and enhancements to BPM ownerMaintain global labeling process consistency across tools, technology, training delivery, procedures, and timelines to enable effective and compliant labeling executionCertification content development for Global Labeling rolesBasic Qualifications Master s degreeORBachelor s degree and 2 years of Regulatory, Compliance or Quality experienceORAssociate s degree and 6 years of Regulatory, Compliance or Quality experienceORHigh school diploma / GED and 8 years of Regulatory, Compliance or Quality experiencePreferred Qualifications Knowledge of pharmaceutical or medical device regulationsAccomplish business results through teamsUse of document management toolsAbility to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respectTime and project management skillsTolerance for ambiguityProficiency in anticipating and resolving problemsProficiency utilizing Microsoft Suite  Outlook, Word, Excel, PowerPointOral and Written Communication and Presentation SkillsPrevious experience working in industry in support of Global Labeling, Regulatory, Engineering or Quality Management/Quality EngineeringAbility to analyze data and report findingsDemonstrates leadership attributesProject ManagementFluent in English (oral and written)Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.


US, California, Thousand Oaks

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