Senior Counsel - Compliance
Key Responsibilities
- Lead design and implementation of a scalable healthcare compliance program aligned with applicable laws, regulations, and industry guidance
- Establish compliance governance, policies, procedures, standards, and risk management frameworks
- Implement transparency and aggregate spend reporting processes
- Proactively identify legal/compliance risks and develop practical mitigation strategies
- Monitor evolving healthcare laws, regulations, and industry trends
- Advise on compliance requirements for HCP interactions, speaker programs, advisory boards, consultants, grants, patient support programs, and medical education
- Provide guidance on the Anti-Kickback Statute, False Claims Act, Sunshine Act, FDA requirements, PhRMA Code, and applicable state healthcare compliance laws
- Develop and oversee compliance monitoring, auditing, and testing programs
- Lead investigations and oversee corrective and preventive action plans
- Create/maintain compliance guidance, SOPs, and training materials
- Oversee transparency reporting and related compliance obligations
- Monitor regulatory developments and assess impact on company practices
- Collaborate with Legal, Regulatory, Privacy, Finance, and HR on compliance governance initiatives
Qualifications
- Bachelorβs degree required; advanced degree preferred
- JD, PharmD, MBA, MPH, or other relevant advanced degree preferred
- 12+ years pharmaceutical/biotech/life sciences compliance experience
- Significant experience building/implementing/leading healthcare compliance programs
- Expertise in healthcare compliance laws (Anti-Kickback Statute, False Claims Act, Sunshine Act, FDA, PhRMA Code)
- Experience supporting commercial launch readiness/commercial-stage operations
- Experience with compliance risk assessments, investigations, monitoring, and auditing
- Experience developing/delivering compliance training
- Prior leadership experience in Compliance/Ethics/Legal or related functions
- Pre-commercial/emerging biotech experience preferred
Core Competencies
- Strategic, proactive compliance leadership; strong business acumen
- Ability to influence senior leaders and drive ethics/accountability
- Strong risk assessment/problem-solving/decision-making
- Excellent communication and training
- Ability to balance compliance oversight with business partnership
- Executive presence with senior leadership/Board
Travel
- Up to 10% travel; often outside local area and overnight.
Benefits/Compensation
- Medical, dental, vision, time off, and 401K; incentive plans contingent on performance
- US Salary Range: $262,022 - $295,584