Full-Time SVP Compliance, Quality & Ethics

THE POSITION: The SVP of Compliance, Quality and Ethics reports to the Chief Compliance Officer. Ensures global compliance with regulations and privacy laws, and all corporate compliance initiatives.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Build & Improve the Company's Regulatory Compliance Program
2. Develop, implement, and maintain compliance systems and procedures for all service lines
3. Develop, implement and maintain internal training procedures related to compliance systems and procedures
4. Present to Board of Directors and Executive Leaders quarterly on compliance status
5. Provide ongoing counsel for outsourcing activities (marketing, sales, HCP interactions, patient advocacy)
6. Provide legal support for Sunshine Act, False Claims Act, Kickback Statue, OIG guidance, PhRMA code, and state pharmacy laws
7. Support and serve as the principal point of contact for regulatory bodies (State Boards of Pharmacy, FDA, HHS, DOJ, DOL)
8. Review outward-facing communications with regulatory implications
9. Keep informed of new laws, regulations and industry trends, and assist with policies and training
10. Secure leadership and management support for compliance standards
11. Develop a balanced compliance environment
12. Ensure compliance training and education for all employees (training sessions, self-service, CBT)
13. Manage compliance inquiries and violations through the helpline and whistleblower services
14. Manage all Governance issues of the Compliance environment globally
15. Maintain and revise policies and procedures to prevent illegal/unethical conduct
16. Manage day-to-day operation of the Compliance Program
17. Develop, review, and update the Code of Conduct
18. Collaborate with other departments to direct compliance issues
19. Consult with legal department on complex compliance issues
20. Respond to alleged violations by evaluating or recommending investigations
21. Develop and oversee a system for handling violations
22. Identify potential compliance vulnerabilities and conduct annual risk assessments
23. Provide reports to senior management on compliance efforts
24. Ensure proper reporting of violations to enforcement agencies
25. Establish and manage the compliance Hotline
26. Institute and maintain a compliance communication program (promoting hotline, Code of Conduct, and compliance issues)
27. Intra-organizational Collaboration: Work with business teams and senior management to ensure awareness of best practices on privacy and data security, collaborate on cyber privacy and security policies, interface with Senior Management to develop strategic plans, assist business units with compliance tools, provide strategic guidance, assist the Chief Information Officer, act as a liaison to the information technology department, collaborate on privacy issues
28. Incident Response: Develop, implement, and train on the Company's Incident Response Plan, mitigate effects of personal information use/disclosure, administer action on privacy complaints
29. Demonstrate a commitment to diversity, equity, and inclusion
30. All other duties as assigned
31. MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: 20+ years Compliance experience, J.D. (optional), Health law expertise (FDA, kickback laws, off-label promotion, FCPA, False Claims Act), Knowledge of managed markets/payers, US and EU privacy laws, experience with building/implementing a privacy program, extensive policy/guidance writing, strong communication skills, ability to drive change, prior in-house experience (preferred)
32. PHYSICAL/MENTAL DEMANDS AND WORKING ENVIRONMENT: Office environment, frequent reaching, grasping, standing/sitting, walking, talking, hearing, occasional lifting/moving up to 25 pounds, moderately quiet environment with interruptions
33. TRAVEL (5-10%, as needed)
34. HOURS (40+ hours per week)

EXPECTATIONS OF THE JOB: The above list reflects general expectations and is not exhaustive.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: 20+ years Compliance experience; J.D. from accredited law school, but not required; Comprehensive knowledge and understanding of relevant legal, regulatory and compliance issues and their practical application; Health law expertise (FDA regulations and guidance’s, federal and state kickback laws, the prohibition against off-label promotion, FCPA, False Claims Act) to advise the company; Knowledge of the managed markets/payer industry, such as PBMs, rebate agreements, specialty pharmacies and related payer groups, as well as Medicare; Knowledge of US and EU privacy laws related to the pharmaceutical and clinical research industry; Experience with building and implementing a privacy program; Extensive experience and skill at writing policies and guidance documents supporting various business activities and conducting investigations; Ability to write clearly and prepare professional communications; Experience working with teams across full corporate structure; Excellent interpersonal and conflict resolution skills and ability to work in a highly collaborative, team-oriented environment; High level of influencing skills and ability to drive change as it relates to implementing remedial actions; Prior in-house experience preferred.

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