Description:

The Senior Director, Senior Compliance Counsel (Senior Compliance Counsel) is a critical leadership role in the daily operation of the Compliance Program Optimization (CPO) pillar of A Pharmaceutical Company compliance program. This position reports to the Executive Director, Compliance Program Optimization (ED, CPO) and serves as the deputy functional leader for the CPO pillar. The Senior Compliance Counsel leads the Compliance Counsel team, provides real-time fraud and abuse risk mitigation guidance to R&D and Commercial business partners, and works collaboratively with cross-functional partners to support A Pharmaceutical Company business priorities. This position may either be based in Rockville, Maryland or Princeton, New Jersey.
The Senior Compliance Counsel serves as the deputy functional leader for the ED, CPO, and supports the ED, CPO in providing enterprise-level strategic advice and guidance to Vice President and US Chief Compliance Officer.

The Senior Compliance Counsel leads the Compliance Counsel team and interfaces with senior leaders on a host of matters. For example, the Senior Compliance Counsel:
  • Provides continuous fraud and abuse risk mitigation advice and guidance to multiple R&D and Commercial functions.
  • Leads Compliance Counsel activities, regularly liaising with R&D and Commercial colleagues at all levels of seniority.
  • Demonstrates excellent business insight and is collaborative with all stakeholders.
  • Leads as the Compliance Counsel voice in communicating proposed changes to the business and finding compliant and operationally feasible solutions.
  • Demonstrates adeptness at foreseeing emerging issues and possible external changes that impact Otsuka's business and finding creative ways to address them and implement changes.

The Senior Compliance Counsel directly supervises the compliance attorneys responsible for providing corporate compliance guidance and training across Otsuka therapeutic areas.

Travel is expected approximately 10% of the time.

Qualifications/ Required
Knowledge/ Experience and Skills:
  • In-depth knowledge of laws (e.g., FD&C, Anti-kickback statute, False Claims Act, Foreign Corrupt Practices Act, PDMA, FDAAA, HIPAA, state laws), regulations, industry guidance and best practices.
  • Excellent interpersonal, communication, and presentation skills.
  • Ability to fully engage various audiences.
  • Proficiency in Microsoft Office.
  • 7+ years of combined relevant experience as: (1) an in-house attorney at a pharmaceutical or medical device company, and/or (2) a law firm attorney in a life sciences or healthcare practice group, or in a related litigation practice group.
  • Demonstrated professional experience as a people leader.

Educational Qualifications
  • BS/BA degree
  • JD required
  • 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.