Associate Monitoring Director, Ethics & Compliance EMEA - United Kingdom
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We currently have a new opportunity within our EMEA Ethics & Compliance group, sitting within the Operations team. The role will be based at our EHQ in Chertsey, UK and will appeal to individuals with Auditing or Monitoring experience. The position has responsibity for development, enhancement, execution and oversight of compliance monitoring programs across EMEA encompassing a variety of Astellas-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 evironment is a key requirement for this role.
- 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