Director - Compliance Counsel

Responsibilities:

• Build, implement, and maintain a robust healthcare and corporate compliance program scaled to the business, products, risk profile, and growth.
• Provide proactive legal/compliance guidance for strategic and tactical initiatives across commercial, medical, regulatory, and corporate activities.
• Advise on sales and marketing strategies and practices under applicable healthcare laws/regulations and industry codes (FDCA, FDA guidance, fraud and abuse, anti-kickback, federal/state transparency, OIG advisory opinions, PhRMA Code).
• Serve as Legal/Compliance representative on Promotional Review and Medical Review Committees.
• Review and advise on interactions and activities involving healthcare professionals/entities/patients and other decision-influencing stakeholders (payers, advocacy groups, distributors, third parties).
• Support medical and commercial development for assigned products, including regulatory/medical strategies, product safety, product liability analyses, and risk mitigation.
• Develop and update compliance policies, procedures, standards, and guidance; support Executive Compliance Committee operations.
• Develop/deliver compliance and ethics training (live and role-based) and foster a speak-up culture.
• Conduct/support investigations; maintain confidentiality; recommend corrective and preventive actions.
• Support compliance risk assessments, monitoring/auditing/remediation with Compliance Operations; participate in internal risk management (e.g., CME grants, investigator-initiated studies, grants/sponsorships).
• Stay current on legal/regulatory/enforcement and translate updates into practical advice, training, and risk mitigation; identify risks/opportunities and manage external counsel.

Requirements:

• Juris Doctor (or equivalent) and admission to a State Bar.
• 5–7+ years legal experience (law firm or in-house), with significant life sciences/commercial biopharma experience; Director/Executive Director-level experience preferred.
• Experience with healthcare compliance areas: advertising/promotion, commercial contracting, HCP interactions, training, investigations, risk assessments, monitoring, and policy drafting/implementation.
• Knowledge of relevant pharma/pharmaceutical laws, guidance, and privacy requirements (FDCA/FDA, fraud/abuse, anti‑kickback, OIG, PhRMA, state marketing/transparency).
• Experience reviewing materials for Promotional/Medical Review.
• Experience developing/implementing compliance programs (policies, training, risk assessments, monitoring).
• Ability to analyze issues quickly and provide business-focused, practical advice.

Preferred/Plus:

• Internal investigation experience; knowledge of managed markets/payer & PBM contracting, patient support programs, government pricing, grants, investigator‑initiated studies, or sponsorships.