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Director, Compliance Investigations

Job in Princeton, Mercer County, New Jersey, 08543, USA
Listing for: Otsuka Pharmaceutical Co.
Full Time position
Listed on 2026-02-16
Job specializations:
  • Business
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 100000 - 125000 USD Yearly USD 100000.00 125000.00 YEAR
Job Description & How to Apply Below

Role Summary

The Director, Compliance Investigations leads the compliance investigation function. This role is accountable for building and sustaining a high‑performing investigations program, integrating advanced analytics to proactively identify risk, and driving remediation and program enhancements that strengthen prevention, detection, and resolution of improper conduct. The Director serves as a strategic partner to Legal, HR, Commercial Leadership, Medical, Internal Audit, and other functions to ensure alignment with state and federal laws, regulatory requirements, industry codes, and internal standards of conduct.

This role will report to the Executive Director, Compliance Program Optimization within the U.S. Ethics & Compliance function.

Key Responsibilities Strategic Leadership & Governance
  • Own the enterprise Investigations operating model—from intake and triage to closure, reporting, and remediation—ensuring consistency, fairness, and defensibility.

  • Lead investigations governance: define decision rights, escalation thresholds, documentation standards, and periodic program reviews.

  • Champion a culture of compliance, integrity, and accountability, with strong alignment to company values and the elements of an effective compliance program.

Investigations Oversight
  • Oversee the end‑to‑end investigations portfolio for alleged non‑compliance in commercial activities (sales, marketing, advertising, promotions); conduct or direct interviews, evidence collection, root‑cause analyses, and formal case summaries.

  • Ensure rigorous documentation and transparency; prepare clear, concise investigative reports and present findings to leadership committees and stakeholders.

  • Partner with Legal and HR as appropriate to maintain confidentiality, privilege, and employee relations standards while exercising sound judgment and discretion.

Risk Analytics & Insights
  • Develop a data analytics capability to proactively identify trends, anomalies, and emerging risk areas; integrate case data, monitoring results, and other relevant sources.

  • Build practical dashboards and risk scoring models (in partnership with Data & Analytics/IT) to detect patterns and inform prioritization, prevention, and targeted remediation.

  • Translate insights into actionable recommendations and track impact over time.

Monitoring, Policies & Training
  • 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.

Leadership & Team Management
  • Manage and develop a Senior Compliance Manager, ensuring strong execution, professional growth, and consistent application of investigative standards.

  • Drive continuous improvement, embedding best practices, metrics, and feedback loops across the investigations lifecycle.

Reporting & Stakeholder Engagement
  • Provide regular program reporting to senior leadership, highlighting trends, themes, systemic issues, and remediation effectiveness.

  • Serve as a trusted advisor to Commercial Leadership, Medical, Legal, HR, Internal Audit, and other stakeholders; facilitate decision‑making and cross‑functional alignment.

Qualifications
  • 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…

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