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Labelling Operations Manager Uxbridge United Kingdom,  

Posted on : 13 May 2017

Project Description

Principal responsibilities include, but are not restricted to:Monitor and triage requests through the BPM tool (LEXA) for timeline waivers and deviations from core or reference label content. Facilitate communication within Global Labeling to provide labeling advice for Response to Questions (RTQ) for global and regional markets (e.g. Reg Affairs, Artwork)Report, track and advise on bundling of core documents to Labeling Strategists and RAMonitor mid- to long-term planning of upcoming CDS/Global labeling changes and project deadlines to Labeling Strategist and Artwork Center.Provide US, EU and other regional labeling operational support, including formatting, templates, SPL, QC, readability, linguistic review, translations, including translation memory management.Support development of labeling templates for all core labelsSupport local regulatory by providing guidance in maintaining data in LEXA and documents EPIC, including clarification of processes.Support projects for changes impacting more than one core label, working across Therapeutic Areas and provides global project management coordinationSupport management of global labeling vendors to ensure established SLA s are met (e.g. translations, Quality Control checks, etc.)Monitor GRAIL for labeling intelligence updates and communicate to Labeling teamSupports US clinical labeling requirements and labeling content statementsSupport initiatives which involve labelingKnowledge and Skills:Previous experience working in industry in support of Global Labeling, Regulatory, Engineering or Quality Management/Quality EngineeringAccomplish business results through teamsProficiency in anticipating and resolving problemsUse of document management toolsUnderstanding the impact of emerging regulatory requirements and there implications for AmgenAbility to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respectAbility to take initiative and drive resultsTolerance for ambiguityProficiency in anticipating and resolving problemsOral and written communication and presentation skillsProject managementRelationship managementEducation and Experience:Degree in pharmaceuticals, natural science or medicinePrevious experience working in industry in support of global labelingProject ManagementVendor ManagementFluent in English (oral and written)Amgen is an equal opportunities employer.HJE2017


United Kingdom Uxbridge

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