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.

Educational Qualifications:

• Juris Doctorate degree; Licensed to practice law in at least one US jurisdiction.
• Competencies
• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

Company benefits:  Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:  

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 

Otsuka is an equal opportunity employer.  All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.   

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting Accommodation Request. 

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives.  They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov,  or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities.  All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.  No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.