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Associate Monitoring Director, Ethics & Compliance EMEA - United Kingdom  

Astellas (company)

Posted on : 23 May 2017

Project Description

  • We currently have a new opportunity within our EMEA Ethics & Compliance group, sitting within the Operations team.
  • The position has responsibility for development, enhancement, execution and oversight of compliance monitoring programs across EMEA encompassing a variety of company-sponsored commercial and non-commercial activities. 
  • The work will involve the development of annual risk assessments and implementing strategies to address identified risks and needs alongside implementing/monitoring plans, tracking, trending and reporting metrics and observations. 
  • The objective is to create an overall governance structure for EMEA. 
  • Working closely with the global Risk & Monitoring group and the country Compliance leads the successful individual will have the opportunity to shape and build a programme currently at the beginning of a large project.
  • Evidence of building and developing these activities in an international Pharmaceutical environment is a key requirement for this role.


Key Activities:  
  • Develop, enhance and execute compliance EMEA monitoring programs related to activities conducted by Commercial, Medical Affairs & R&D, developing & implementing an effective risk-based monitoring program to address identified and emerging compliance risks. 
  • Evaluate local risk assessments, prior monitoring observations, identified and emerging risk areas, legal and regulatory codes, industry trends, and past and planned business activities. 
  • Develop, enhance and implement policies, procedures and processes necessary to execute, document and report the Company s monitoring activities and identify/manage electronic systems, solutions and resources to achieve this 
  • Oversee the successful implementation of annual monitoring plans for EMEA in conjunction with local Compliance Leads.   
  • Ensure timely and accurate tracking of planned and completed monitoring, documentation of findings, and determination and completion of corrective action to address identified issues.   
  • Identify potential activities for monitoring, ensure selection of appropriate monitoring samples, develop and enhance testing criteria, collect and analyze relevant materials, develop and document monitoring observations, communicate findings and policy/process gaps, and ensure the preparation and maintenance of appropriate monitoring files and documentation.   
  • Develop, manage and track monitoring metrics, trends and observations, develop and prepare periodic monitoring reports, and present conclusions and corrective action plans resulting from monitoring activities to Ethics & Compliance leadership, functional business leadership, and other relevant stakeholders.   

Requirements for this role:
  • Proven compliance expertise within a Pharmaceutical environment to understand and comply with industry laws and relevant regulations. 
  • Proven experience in auditing, monitoring or compliance activities 
  • Demonstrated project management skills and the ability to work independently on multiple projects simultaneously to tight deadlines. 
  • Evidence of ability to exercise independent judgment, objectivity, able to handle confidential information with discretion and effectively collaborate with multiple functional units. 
  • Possess good initiative and problem-solving skills, to proactively identify issues, anticipate needs and develop practical, meaningful solutions. 
  • Proven ability to influence, (appropriately) challenge and engage diverse senior stakeholders.   
  • Fluent in written and verbal business English with confident presentation skills 
  • Candidates must possess eligibility to work in the UK without the need for sponsorship 

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