Senior Counsel, Commercial and Compliance
New
Fully remote work environment with flexibility across the United StatesFull-TimeSenior
Salary250,000 - 285,000 USD per year
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Job Details
- Experience
- 8–12+ years
Requirements
- Juris Doctor (J.D.) degree and active bar membership in at least one U.S. jurisdiction.
- 8–12+ years of legal experience, ideally within biotech or pharmaceutical environments (in-house strongly preferred).
- Proven experience supporting commercial product launches and commercialization activities.
- Strong expertise in healthcare compliance laws and regulations, including FDA, OIG guidance, Anti-Kickback Statute, False Claims Act, PhRMA Code, and Sunshine Act.
- Hands-on experience with MLR/PRC review processes and promotional regulatory frameworks.
- Demonstrated ability to draft and negotiate complex commercial agreements.
- Experience building or scaling compliance programs in a regulated life sciences environment.
- Strong strategic thinking, risk assessment, and problem-solving capabilities.
- Excellent communication and stakeholder management skills.
- Leadership mindset with a pragmatic, solution-oriented approach and strong ethical judgment.
Responsibilities
- Serve as the primary legal advisor to Commercial and Medical Affairs teams, providing day-to-day and strategic guidance on business initiatives.
- Support commercialization readiness, including launch planning, market access strategies, patient support programs, and distribution models.
- Draft, review, and negotiate a wide range of commercial agreements, including vendor contracts, speaker programs, advisory boards, and sponsorship arrangements.
- Lead legal review of promotional and medical materials through MLR/PRC processes, ensuring compliance with applicable regulations.
- Advise on compliant interactions with healthcare professionals, patients, payors, specialty pharmacies, and government entities.
- Guide commercial and medical activities such as scientific exchange, advisory boards, grants, and medical information requests.
- Design and implement a scalable healthcare compliance program, including policies, training, monitoring, and reporting frameworks.
- Oversee transparency reporting and aggregate spend compliance processes.
- Identify legal and compliance risks and develop practical, business-oriented mitigation strategies.
- Monitor evolving healthcare regulations and industry standards, translating them into actionable guidance for leadership.
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