[Remote] Deputy General Counsel / Vice President, Healthcare Law & Compliance

Note: The job is a remote job and is open to candidates in USA. LB Pharmaceuticals Inc is seeking a senior legal leader to guide legal strategy for planned commercialization activities and lead healthcare regulatory matters. The role oversees and builds the healthcare compliance function, advises cross-functional teams, and manages a high-performing healthcare law and compliance team.

Responsibilities

• Advise members of the leadership team on a wide range of commercialization issues with broad enterprise impact
• Serve as legal representative on Commercial and Medical committees and teams, including promotional review, medical materials, and educational and charitable grants
• Serve as lead counsel for healthcare regulatory law, including the FDCA and related regulations and guidance documents, fraud and abuse laws and guidance (Anti-Kickback Statute, False Claims Act, OIG guidance and advisory opinions), and federal and state transparency and reporting laws
• Oversee the company’s healthcare compliance function and build, implement, and maintain a healthcare compliance program consistent with industry best practices
• Develop and maintain healthcare compliance policies, procedures, and controls, including those governing promotional materials, scientific exchange, and interactions with healthcare professionals and patients
• Oversee healthcare compliance training, auditing and monitoring, risk assessments, and investigations, and reporting processes
• Lead the company’s federal and state transparency and aggregate spend reporting
• Provide strategic legal advice on patient support programs, patient hubs, and market access, and oversee commercial contracting
• Monitor emerging healthcare regulatory and healthcare compliance trends, and assess and communicate their impact on the company
• Build and manage a high-performing healthcare law and compliance team in a dynamic, high-growth environment

Skills

• JD degree
• Active membership in good standing with a State Bar
• 15+ years of legal experience, including leadership experience 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 that build trust and alignment across functions
• Ability to maintain confidentiality and operate with the highest ethical standards and professionalism
• Sence of urgency

Benefits

• Remote work

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