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Healthcare Compliance Manager - Compliance Platform & Operations United Kingdom,  

Amgen (company)

Posted on : 01 May 2017

Project Description

The company:
  • Our company 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, our company  has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. 
  • Our company  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.

  • 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 company 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 requirements
  • Provides 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 staff
  • User Acceptance Testing (UAT) - Conducts regional UAT & train country testers in UAT for Automation & Disclosure systems
  • Support: Manage disclosure support mailbox, action / escalate as required; point of contact for country user/super-users;
  • Key Performance Indicators (KPI)- Develops & tracks KPIs
  • Continuous improvement  conducts feedback surveys/ reviews & creates plans/tracking for implementation of continuous improvements related to Automation & Disclosure
  • Quality checks - Design, maintain and continuously improve quality checklists and associated training;  Maintain overview of completion, analyse & communicate outcomes
  • Disclosure Consent - Administer Consent Notification Form SharePoint site; agree annual HCR consent status; assist countries with bulk consent uploads
  • Disclosure 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 company web team

Competitive salary & comprehensive benefits package including bonus scheme

Basic qualifications:
  • Bachelors degree or equivalent in Life Sciences, Business or related discipline or relevant experience (see below)
  • Fluency in English
  • Related compliance experience with at least 2 years direct experience of implementing compliance systems & tool
  • Working knowledge of EFPIA Codes (Healthcare Professional; Patient Organization & Disclosure)

Preferred Qualifications and Experience:
  • Developing & delivering communications & training
  • Working with cross-functional teams
  • Understanding of country Code requirements
  • System user acceptance testing
  • Excellent oral and written communication skills
  • Additional languages
  • Training experience (virtual & face to face)
  • Project management
  • Knowledge about applicable laws and regulations

Key Competencies:
  • Awareness of cultural diversity
  • Ability to work in a highly matrixed organization
  • Negotiation, collaboration, persuasion, communication and relationship building skills with the ability to resolve concerns
  • Developing & reporting metrics
  • Issue management
  • Managing requirements
  • Presentation skills
  • Scope/change management
  • Self-leadership/motivation
  • Status reporting
  • Technical solution evaluation
  • Subject matter knowledge
  • Highest level of integrity
  • Discreet and able to protect confidential information
  • Role model for ethical behavior
  • Investigative and problem solving skills
  • Ability to work under time pressures
  • Detail orientated with accurate analytical skills
  • Multi-tasking
  • Supplier/Contract Management


United Kingdom Cambridgeshire

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