Sr. Director, Corporate Compliance

New
K
Emeryville, CA (Hybrid) or west coast remoteFull-TimeDirector
Salary not disclosed
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Job Details

Experience
12+ years
Required Skills
Project ManagementHIPAA

Requirements

  • Bachelor's degree in Business, Life Sciences, Healthcare Administration, or a related field (Advanced degree preferred).
  • 12+ years of progressive experience in pharmaceutical, biotechnology, medical device, or healthcare compliance.
  • Experience supporting commercial organizations.
  • Demonstrated success building or enhancing enterprise compliance programs in a clinical-to-commercial stage organization.
  • Strong knowledge of healthcare laws and regulations, including FDA promotional requirements, Anti-Kickback Statute, False Claims Act, Sunshine Act/Open Payments, PhRMA Code, and HIPAA.
  • Exceptional program and project management skills.
  • Experience developing and executing multi-year compliance roadmaps and governance structures.
  • Proven ability to influence stakeholders and drive strategic cross-functional initiatives.
  • Demonstrated ability to manage multiple strategic initiatives simultaneously.
  • Strong organizational and operational leadership skills.

Responsibilities

  • Serve as the program manager for enterprise compliance buildout and commercialization-readiness initiatives.
  • Develop and execute the enterprise compliance program strategy and roadmap.
  • Lead day-to-day operations of the Compliance function, including governance, policies, and systems.
  • Partner with executive leadership and cross-functional teams to integrate compliance into corporate strategy.
  • Provide guidance on healthcare compliance risks related to commercialization and interactions with healthcare professionals.
  • Establish risk-based third-party compliance diligence, onboarding, and monitoring processes.
  • Measure program effectiveness through metrics and periodic assessments.
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