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ProfileDirector, Investigations, Monitoring and Risk Assessment The candidate will be accountable and responsible for leading the Americas Ethics and Compliance (EandC) internal investigations and hotline reporting functions, periodic risk assessments, and monitoring across a wide variety of commercial and non-commercial activities in the Americas. Will provide strategic direction and leadership to ensure that the findings and observations in the investigations, risk assessment and monitoring processes are fully integrated and enabled to most effectively identify and mitigate risk. Work closely with Ethics and Compliance global, regional and local personnel, the business in the Americas, and global EandC Group Operations to most effectively manage risk and lead operational effectiveness, efficiency and consistency in the above areas. The Director is a strong leader and promotes a highly ethical, compliant and accountable culture that encourages and enables employees to raise potential or actual compliance concerns. Have an excellent track record enhancing and leading investigations, hotline reporting as well as other risk mitigation strategies such as healthcare compliance and anti-bribery anti-corruption risk assessments, data analytics, business self-monitoring and compliance monitoring strategies in an Ethics and Compliance function. Responsible for strategically leading, assessing and incorporating Investigations, risk assessment and monitoring findings into business self-monitoring, compliance monitoring, audit, training/communications, and policy/process functions. Leading the internal compliance investigations program, including leading an investigations team in a matrixed function to conduct and oversee the hotline/reporting process and EandC investigations in collaboration with Legal and Human Resources. The investigations program includes all Americas investigations as well as cross-border investigations. Developing strategy for internal EandC investigations and effectively conducting and overseeing internal investigations to ensure that they are conducted in a respectful, effective and efficient manner consistent with policies/procedures and best practices. Training new investigators to prepare investigation plans, conduct interviews and document reviews, analyze all relevant information, prepare investigation reports, and present conclusions and findings in precise and clear manner. Developing strategy for and overseeing the management, tracking and development of investigation metrics and trends, periodic investigation reports and reporting of various metrics to EandC, senior leadership, Americas Compliance Committee, and other key business stakeholders. Regularly presenting and supporting presentations to senior leadership on investigations and investigation trends. Developing strategy for and leading annual compliance risk assessments to identify, prioritize and evaluate the Company's key risk areas across the organization and, as appropriate, strengthen controls and policies and procedures, increase training and communications, and develop and oversee annual risk mitigation and enhanced monitoring plans as needed. Lead collaboration with business leaders on risk assessment, sharing output with senior and functional business leaders and incorporation of output of assessments into business activities. Develop strategy for and lead development of organizational compliance risk mapping which identifies risk mitigation activities across functions in various compliance risk areas. Oversee and develop strategy for effective risk-based business self-monitoring and compliance monitoring programs in the Americas across a variety of Astellas-sponsored activities, including without limitation, activities conducted by the Astellas Commercial, Medical Affairs, and Research and Development organizations to address identified and emerging compliance risks and oversee the management of the infrastructure necessary to support the program. Oversee and develop strategy for the development, enhancement and implementation of policies, procedures and processes necessary to execute, document and report the Company's monitoring activities, including monitoring dashboards and trackers, reporting tools, and corrective action plans. Oversee the identification, implementation and management of electronic systems, solutions and other resources to enhance overall efficiency and effectiveness of the compliance monitoring program. Lead the development of annual business self-monitoring plans (in close collaboration with the business) and compliance monitoring plans, taking into account prior investigations and monitoring observations, identified and emerging risk areas, OIG guidance, industry trends, and past and planned business activities. Develop strategy and lead seamless integration between trends identified in hotline reporting and investigations with monitoring, training, and policy/process teams. Proactively communicate investigation findings and conclusions, monitoring trends and recommendations to senior leadership and Americas Compliance Committee. Coordinate with regional and global Internal Audit, CRQA, QA, TandE, Finance, Legal, and the Business, as appropriate, to ensure that issues, gaps and trends identified through investigations, monitoring and other means are understood and timely addressed and that mechanisms are in place to monitor the effectiveness of process improvements. Develop strategy for, lead and develop effective change management plans to effectively deliver on position objectives. Lead, develop strategy, evaluate and contribute to the improvement of governance, risk management, and control processes for the areas being assessed through investigations, risk assessments, business self-monitoring and compliance monitoring activities. Directly reports to the Executive Director, Healthcare Compliance, Monitoring and Investigations, Americas. Works closely and collaborates with Ethics and Compliance local, regional and global leadership and operations. Collaborates with approved team members via matrix global organization and manages at least two direct reports, including at least 1 Associate Director and 1 Senior Manager. Leads and ensures the effective implementation of the Americas Investigations Risk Assessment and Monitoring programs closely coordinates with Ethics and Compliance counterparts across the globe. Works with all company operational areas and employee levels in gathering, evaluating, and communicating information about the activity or process being examined. Works closely and collaborates with leadership in the Americas.
Qualification and Experience
The candidate must have 10+ years of experience in Compliance or related functions (e.g., regulatory, legal, audit, or risk). Must have Advanced degree (Juris doctor; Masters; Ph.D) or advanced compliance certifications (CCEP or equivalent). Expertise in compliance with law, regulations and industry codes relevant to the pharmaceutical industry. Sophisticated knowledge of the best practices relating to compliance in highly regulated industries is required. Demonstrated experience leading compliance operations projects and activities in a matrixed, global organization is required. Excellent written and verbal executive-level communication skills is required. Experience working globally is preferred. 5+ years of supervisory or project management experience. Is desired.