Director, Compliance Investigations

* Support and enhance field monitoring activities (e.g., ride-alongs, speaker program monitoring, record reviews of call notes/emails) to validate controls and detect issues early.
* Co‑own the creation and continuous improvement of policies and procedures aligned to Anti‑Kickback Statute, HIPAA, False Claims Act (FCA), PDMA, FDCA, FDAAA, FCPA, Sunshine Act, PPACA, and applicable state reporting statutes.
* Develop and deliver engaging training and practical tools for internal customers; keep colleagues current on evolving compliance requirements and best practices.
* Bachelor’s degree required; J.D. strongly preferred.
* 7+ years of compliance experience in the pharmaceutical industry; medical device experience is a strong plus.
* Deep knowledge of pharmaceutical commercial operations and how effective compliance programs are designed, communicated, and managed.
* Demonstrated expertise with applicable laws and regulations, industry guidelines, and best practices (e.g., Anti‑Kickback, FCA, HIPAA, PDMA, FDCA, FDAAA, FCPA, Sunshine Act, PPACA; and relevant state statutes).
* Proven ability to handle confidential and sensitive matters with a high degree of judgment, discretion, and professionalism.
* Exceptional written and oral communication skills—able to distill complex issues into executive‑ready narratives and actionable recommendations.
* High proficiency with Microsoft 365 (Word, Excel, PowerPoint, Teams) and familiarity with compliance case management and analytics tools.
* Initiative, independence, and sound judgment—able to operate with autonomy while engaging effectively across functions.
** 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.

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.

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 Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations.

In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.
#J-18808-Ljbffr