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About the Role

This is a strategic, high-impact role for an experienced healthcare attorney with deep FDA regulatory and fraud and abuse expertise. The role involves leading cross-functional legal and compliance strategy, providing guidance on commercialization activities, and overseeing the company's compliance function.

Responsibilities

Advise leadership on commercialization issues with enterprise impact.
Serve as legal representative on Commercial and Medical committees, including promotional review, medical materials, and educational/charitable grants.
Act as lead counsel for healthcare regulatory law, including FDCA, fraud and abuse laws, and federal/state transparency and reporting laws.
Oversee and build/implement/maintain a healthcare compliance program consistent with industry best practices.
Develop and maintain healthcare compliance policies, procedures, and controls for promotional materials, scientific exchange, and interactions with healthcare professionals/patients.
Oversee healthcare compliance training, auditing, monitoring, risk assessments, investigations, and reporting.
Lead federal and state transparency and aggregate spend reporting.
Provide strategic legal advice on patient support programs, patient hubs, and market access; oversee commercial contracting.
Monitor emerging healthcare regulatory and compliance trends and assess their impact.
Build and manage a high-performing healthcare law and compliance team.

Requirements

JD degree.
Active membership in good standing with a State Bar.
15+ years of legal experience, including leadership at a commercial-stage biotech or pharmaceutical company.
Demonstrated experience building, leading, or overseeing a healthcare compliance program.
Deep familiarity with FDA advertising and promotion compliance.
Experience supporting product launches.
Strong contracting acumen; ability to advise clinical, medical, and commercial teams.
Exceptional executive communication, stakeholder management, and negotiation skills.
Ability to convey complex legal risks in clear, business-centric terms.
Experience hiring and developing legal and healthcare compliance teams.
Collaborative, flexible, and pragmatic work style with excellent interpersonal skills.
Ability to maintain confidentiality and operate with the highest ethical standards.
Sense of urgency.

Skills

FDA regulatory expertise
Fraud and abuse expertise
Legal strategy
Compliance strategy
Healthcare regulatory law
FDCA
Anti-Kickback Statute
False Claims Act
OIG guidance
Federal and state transparency and reporting laws
Healthcare compliance program development
Policy development
Procedure development
Control development
Training
Auditing
Monitoring
Risk assessments
Investigations
Reporting
Aggregate spend reporting
Patient support programs
Market access
Commercial contracting
Executive communication
Stakeholder management
Negotiation
Team building
Team management
Interpersonal skills

Experience Level

15+ years of legal experience
Leadership experience

Education Level

JD degree

Salary/Compensations

$350,000-$390,000

About the Company

Purpose Driven – Optimistic, focused, committed to vision, hard-working, compliant, relentless, impatient in pursuit of treatments, setting competitive goals to impact patients, employees, and shareholders, sense of urgency.
Transparent – Trusting, honest, open communication, humble, genuine, direct, accountable, embracing tough conversations.
Bold – Courageous in pursuit of excellence, unafraid of risks, challenging assumptions, challenges, and success.
Intelligent – Curious, passionate, self-aware, agile, adaptable, seeking diverse experience/knowledge/skills, making informed data-driven decisions, anticipating needs, adapting quickly, finding solutions, relying on collective experiences.
Unified – Collaborative, striving for excellence, relying on each other, encouraging constructive feedback, supporting each other, laughing together, celebrating successes, banding together in hardship, fostering genuine relationships.
Values underpin the employee experience, demonstrating character and personality through communication, support, time allocation, decision-making, and collective celebration.