Manager, Governance, Risk Management & Compliance; GRC Auditor

Following the implementation of the Governance, Risk Management, and Compliance (GRC) program and Enterprise Risk Management (ERM) Assessment in the U.S., this role will support the U.S. Ethics & Compliance (E&C) operational audit program and risk management activities.

The Manager, GRC Auditor will conduct planning, execution, and reporting of operational audits, tabletop assessments, and other ad-hoc reviews on behalf of Otsuka America Pharmaceutical, Inc. (OAPI) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), collectively Otsuka. This will support effective risk management and compliance by providing assurance services through independent audits and reviews of Otsuka’s enterprise and US compliance risks and business activities.

This role supports U.S. E&C's GRC function and the Vice President & U.S. Chief Compliance Officer in executing an effective compliance program.

• Execute a U.S. Compliance audit program that provides assurance over Otsuka’s enterprise and U.S. compliance risks and helps to detect and prevent fraud.

• Update the audit universe based on engagement with stakeholders to ensure it is focused on the highest-risk activities and remains fit-for-purpose.

• Conduct audits and other independent assessments of Otsuka’s enterprise and compliance risks, by assessing the design and operating effectiveness of internal controls (through detailed transaction testing) to identify control gaps or risks.

• Support development and execution of audit process steps, including drafting announcement memos, designing audit testing procedures, interviewing stakeholders, reviewing and testing internal controls, executing sampling methodology, reviewing supporting documentation, and documenting testing procedures, findings, and observations.

• Validate audit findings and observations with management and communicate final audit results to management, through presentations and written reports that address findings, risks, root cause analysis, and recommended actions.

• Draft formal written audit reports or other Compliance reports for the U.S. business that are clear, concise, and drive meaningful action to strengthen controls and mitigate risks.

• Support management of third-party consultants and actively oversee audits conducted by third-parties on Otsuka’s behalf, ensuring audit quality and on-time delivery.

• Track and follow-up on management action plans to ensure they are completed timely and effectively.

• Partner with U.S. Compliance Counsel and other functional areas to recommend pragmatic risk mitigation or remediation actions.

• Establish and maintain effective relationships with internal stakeholders and collaborate with internal partners.

• Provide feedback and/or drafts sections of reports and documents intended for submission to various organizational committees.

• Maintain a working knowledge of relevant trends, laws and regulations pertaining to healthcare law, regulatory compliance, and auditing. Assists in developing or improving processes and procedures that promote compliance with healthcare laws, regulations and guidance.

• Identify opportunities and supports further development of the COMPLi system, Otsuka’s U.S. E&C data analytics platform.

• Conduct other risk management activities or duties to support the U.S. E&C GRC and Healthcare Law Auditing and Monitoring teams.

• At least 4 - 7 years of experience performing auditing or monitoring activities and strong understanding of enterprise risk management frameworks, internal controls, and risk assessment and audit methodologies

• Excellent communication skills (verbal and written)

• Experience with regulators, external auditors, and/or independent review organizations

• Bachelor's degree in Accounting, Risk Management, or a related field

• Certified Public Accountant (CPA), Certified Internal Auditor (CIA), Certified Information Systems Auditor (CISA) or other certification or professional designation in accounting, compliance, or auditing

• Pharmaceutical industry experience

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and…