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Astellas Pharma Senior Manager, Ethics & Compliance Monitoring in Northbrook, Illinois

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing a Senior Manager, Ethics & Compliance Monitoring opportunity in Northbrook, IL.

Purpose & Scope:

The position plays a key role in Ethics & Compliance in support of the following:

  • The development, enhancement, and execution of risk-based compliance monitoring programs across a variety of Astellas-sponsored commercial and non-commercial live and transactional activities.
  • Planning and conducting risk assessments; executing data analytics; assisting the business with self-monitoring, assisting and/or preparing required presentations/reporting; conducting root cause analyses; developing and implementing strategies to address and mitigate identified risks.
  • Serving as a resource to support the development and enhancement of compliance monitoring programs in other Astellas affiliates.
  • Demonstrating good judgment and following organizational and professional ethical standards.

Essential Job Responsibilities:

  • Responsible for timely and accurate execution of risk-based compliance monitoring programs (live and transactional) across a variety of Astellas business activities, including activities conducted by the Astellas Commercial, Medical Affairs, and Research and Development organizations.
  • Under minimal supervision, develops and enhances testing criteria, ensures selection of appropriate monitoring samples, collects and analyzes relevant documentation, develops and documents monitoring observations, ensures the preparation and maintenance of appropriate monitoring workpapers, reporting and related documentation and communicates findings.
  • Executes, documents and reports on the risk mitigation activities, including developing and/or maintaining monitoring dashboards, issue tracking mechanisms, and related reporting tools.
  • Manages and tracks monitoring metrics, trends and observations. Develops and prepares periodic monitoring reports/presentations as necessary for E&C and business leadership, the US Compliance Committee, and other relevant stakeholders as appropriate.
  • Assists with the development and implementation of monitoring and remediation activities to enhance the overall efficiency and effectiveness of the compliance monitoring program and/or to meet regulatory and/or business requirements. This includes, but is not limited to, developing, enhancing and implementing monitoring activities (including expanded data analytic monitoring capabilities) as well as policies, procedures and processes.
  • Identifies, implements and manages systems/applications, solutions and other resources to enhance and maintain overall efficiency and effectiveness of the compliance monitoring program.
  • Assists in the training, development, management and oversight of compliance monitoring co-source partners.
  • Conducts risk assessments to identify, evaluate and prioritize the Company's potential risk areas, taking into account prior monitoring observations, identified and emerging risk areas, OIG guidance, industry trends, and past and planned business activities. Interviews business leaders and partners with internal stakeholders, including Internal Audit and Quality Assurance, to ensure communication and collaboration of auditing and monitoring plans.
  • Ensures that monitoring findings, observations and trends, as appropriate, are integrated into compliance and business policies, processes, training and communications to most effectively mitigate risk.
  • Serves as a monitoring resource to support the development, implementation and enhancement of E&C monitoring programs in other Astellas affiliates.

Quantitative Dimensions:

This position will evaluate and contribute to the improvement of business processes across a variety of Astellas commercial and non-commercial business activities through the development, execution and oversight of risk-based compliance monitoring programs. It will also assist in supporting Astellas with risk assessment and mitigation processes pertaining to the Corporate Integrity Agreement.

Organizational Context:

Position reports to the Director, Monitoring & Risk Mitigation who reports to the Executive Director, Healthcare Compliance & Risk Mitigation. Position works with all company functional/operational areas and employee levels in gathering, evaluating, and communicating information about the activity or processes being reviewed. This position will collaborate with various groups both within and outside of E&C

Qualifications:

Required

  • BS /BA degree from an accredited college or university.
  • 7+ years of full-time experience in auditing and/or compliance monitoring.
  • Advanced level Excel skills (e.g., sumif, vlookup, hlookup, rank, count if, if statements, etc to be able to properly manipulate and report data).
  • Minimum of 3 years of relevant pharmaceutical/healthcare industry experience in a compliance, internal audit, or business consulting role.
  • Knowledge of pharmaceutical industry laws and regulations and related compliance issues.
  • Possesses a natural curiosity, strong orientation to detail and the ability to work in a fast-paced environment.
  • Demonstrated project management skills and the ability to work on multiple projects simultaneously with little supervision under tight deadlines.
  • Demonstrated initiative and problem-solving skills, including the ability to proactively identify issues and develop practical, meaningful solutions.
  • Demonstrated ability to exercise independent judgment, objectivity, handle confidential information with discretion and effectively collaborate with multiple functional units.
  • Demonstrated ability to interact with and present information to colleagues with the appropriate respect and sensitivity.

Preferred

  • Prior supervisory experience.
  • Developed and/or assisted in the development/implementation of a compliance monitoring program within the pharmaceutical industry.
  • Professional / advanced degree or certification such as a MBA, JD or CPA.
  • Prior experience using a data analytics tool (e.g., Qlikview, Tableau).

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Ethics and Compliance

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