||• 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.