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Healthcare Compliance Manager - Compliance Platform & Operations United Kingdom,  

Posted on : 01 May 2017

Project Description

Title: Healthcare Compliance ManagerThe company:Amgen is one of the world s largest independent biotechnology companies, with global revenue in excess of $18 billion and over 18,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.Responsibilities:Championing compliance best practices of the organization.Provide advice, guidance, direction and support to the Compliance Leads/HQ/ Functional Leads on interpretation and implementation of the Regional Codes (e.g. EFPIA) and legislation and how it impacts Amgen processes & systems (e.g. C3, Disclosure)Demonstrating a thorough knowledge of compliance objectives and processes that impact compliance requirements and translate these into system or reporting requirementsProvides training & process support to multiple departments or functional areas.Understands the compliance, business drivers and strategy and is an advocate for compliance within the business.Applies skills to create, modify or expand compliance training, system solutions, related processes and programs for projects. Key Activities: Country Requirements - Analyse, review with country / regional lead and feed new or revised requirements to technical teams (including requirements, existing system landscape, gap analysis, plan of action to minimize impact on business, data collection & tools)Communications and Training - Develops, maintains and implements communications and training on system solutions/enhancements & quality checks; manages training & assessment for HCR access requests & access deletions; conduct 3rd Party trainings (as necessary related to Disclosure & Automation) and/or follow up training was conducted by affiliate staffUser Acceptance Testing (UAT) - Conducts regional UAT & train country testers in UAT for Automation & Disclosure systemsSupport: Manage disclosure support mailbox, action / escalate as required; point of contact for country user/super-users;Key Performance Indicators (KPI)- Develops & tracks KPIsContinuous improvement  conducts feedback surveys/ reviews & creates plans/tracking for implementation of continuous improvements related to Automation & DisclosureQuality checks - Design, maintain and continuously improve quality checklists and associated training; Maintain overview of completion, analyse & communicate outcomesDisclosure Consent - Administer Consent Notification Form SharePoint site; agree annual HCR consent status; assist countries with bulk consent uploadsDisclosure Report Publication - Maintain / update Methodological Note; monitor timely report publication; coordination of visitor tracking with web team; co-ordination of Patient Organisation disclosure reporting; co-ordination of the publication of disclosure reports with the Amgen web team Location: Cambridge, UKRemuneration:Competitive salary & comprehensive benefits package including bonus schemeBasic qualifications:Bachelors degree or equivalent in Life Sciences, Business or related discipline or relevant experience (see below)Fluency in EnglishRelated compliance experience with at least 2 years direct experience of implementing compliance systems & toolWorking knowledge of EFPIA Codes (Healthcare Professional; Patient Organization & Disclosure) Preferred Qualifications and Experience:Developing & delivering communications & trainingWorking with cross-functional teamsUnderstanding of country Code requirementsSystem user acceptance testingExcellent oral and written communication skillsAdditional languagesTraining experience (virtual & face to face)Project managementKnowledge about applicable laws and regulations Key Competencies:Awareness of cultural diversityAbility to work in a highly matrixed organizationNegotiation, collaboration, persuasion, communication and relationship building skills with the ability to resolve concernsDeveloping & reporting metricsIssue managementManaging requirementsPresentation skillsScope/change managementSelf-leadership/motivationStatus reportingTechnical solution evaluationSubject matter knowledgeHighest level of integrityDiscreet and able to protect confidential informationRole model for ethical behaviorInvestigative and problem solving skillsAbility to work under time pressuresDetail orientated with accurate analytical skillsMulti-taskingSupplier/Contract ManagementAmgen is an equal opportunities employer.HJE2017


United Kingdom Cambridgeshire

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