Executive Director, Compliance Program Optimization

Otsuka is a global healthcare company that has been in business for more than 100 years driven by the corporate philosophy: "Otsuka people creating new products for better health worldwide." We are committed to researching, developing, manufacturing, and marketing innovative products, with a strong focus on pharmaceutical treatments for diseases and nutraceutical products to maintain everyday health. Our pharmaceutical efforts emphasize developing and commercializing therapies in Neuroscience, Nephrology, and Immunology, along with research programs targeting various unmet specialty disease areas.

The Executive Director, Compliance Program Optimization (CPO), will facilitate execution of the strategy developed by the Vice President & US Chief Compliance Officer (CCO) to mitigate risk and enable business success. The successful leader in this role is a consummate learner and teacher who can understand an increasingly complex landscape and translate learnings into concrete solutions and actions needed to protect the organization.

Reporting directly to the CCO, the Executive Director, CPO will drive:

Strategic Optimization

• Continuously assess execution of seven fundamental program elements, and where necessary direct implementation of CCO-endorsed program enhancements.  

• Survey and summarize enforcement trends relevant to the pharmaceutical business, providing regular and succinct updates to the CCO and, where applicable, proposing commensurate compliance program enhancements. 

• Ensure seamless and constant coordination of risk mitigation activities across the four functional pillars of US Ethics and Compliance: (1) Governance, Risk Management & Compliance; (2) Training & Documentation; (3) Compliance Program Optimization; and (4) Information Security.   

• Maintain register of business initiatives and programs for which risk mitigation guidance has been provided, and as needed, direct contemporaneous and/or retrospective program reviews to assess adherence to guidance.   

• Use in-depth and comprehensive understanding of Otsuka's North American Strategy to provide CCO with recommendations regarding compliance resource allocation.  

Program Execution

• Directly supervise US E&C Compliance Counsel, Internal Investigations, and Operations teams, with management responsibility for at least eight FTE reports.    

• Develop, implement, and continually assess compliance counsel business support model, including but not limited to ongoing prioritization and enhancement of business acumen and fraud and abuse expertise.

• Oversee Internal Investigations and Conflict of Interest (COI) processes, actively researching and incorporating best practices into existing models to ensure continuous improvement.

• Oversee Compliance Operations, ensuring seamless interconnectivity of fundamental programmatic elements.

Stakeholder Communication

• Synthesize and continually enhance compliance reporting model, to ensure uniform, consistent and cohesive narrative of CCO's strategy across all compliance reports, including but not limited to Compliance Committee updates, quarterly reports to the OAPI/OPDC Audit & Risk Committee and Joint Boards of Directors, Annual reports, and updates to the Global Compliance Oversight Committee (GCOC). 

• Formalize and enhance interdepartmental communication between US E&C and the business, as well as between US E&C and other enabling functions (including, but not limited to, Legal, Regulations, and Business Optimization (LRBO)), to ensure timely provision and receipt of relevant information.

Knowledge/ Experience and Skills:

Requirements:

• Minimum of 15 years of: (1) in-house counsel experience in the pharmaceutical industry; and/or (2) law firm experience specific to the pharmaceutical industry.

• Minimum of 7 years of experience supervising and/or conducting internal investigations.

• Proven leadership ability and strong influencing skills, with a minimum of 7 years of experience directly managing full-time equivalent (FTE) employees.

• Expert level understanding of US healthcare industry laws and regulations.

• Expert level understanding of DOJ and OIG guidance for effective corporate compliance programs. 

• Direct experience implementing government-mandated corporate remediation measures, including, for example, those set forth under corporate integrity agreements or deferred prosecution agreements.

• Strong interpersonal, writing, communication, organizational, project management and presentation skills.

• Proficiency in Microsoft Office Suite.

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