Healthcare Regulatory Counsel

SmithRx
Summary
Join SmithRx, a rapidly growing Health-Tech company, as a Healthcare Regulatory Counsel to ensure compliance within the dynamic PBM regulatory landscape. You will collaborate with cross-functional teams, providing strategic legal advice and support for regulatory compliance. Responsibilities include reviewing and analyzing federal and state laws, advising on new products and services, supporting contract negotiations, and maintaining compliance across various business functions. The ideal candidate possesses a J.D. degree, active state bar membership, and 5+ years of experience in healthcare regulatory matters, particularly within the pharmaceutical industry and PBMs. A passion for improving healthcare access and a strong analytical mindset are essential. SmithRx offers competitive benefits, including health insurance, retirement plans, paid time off, and professional development opportunities.
Requirements
- J.D. degree and active membership in at least one state bar
- Admitted to California bar, or admitted/eligible to qualify as a California Registered In-House Counsel
- 5+ years of experience as a practicing attorney at a law firm and/or in-house in healthcare regulatory matters
- Relevant experience and strong foundation in the healthcare legal/regulatory frameworks affecting the pharmaceutical industry and PBMs, including working knowledge of HIPAA, PBM/TPA licensing, anti-kickback statutes, utilization review laws, pharmacy laws, and ERISA
- Experience interacting with government administrative agencies and regulators
- Strong written and oral communication skills to effectively collaborate and negotiate with internal stakeholders and external counterparties
- Highly analytical and solutions-focused with sound business judgment
- Quick learner who can adapt to a fast-paced, high-growth environment and can navigate complex cross-functional situations
- Works well under pressure, with regular prioritization and timely and transparent communication
- Has an interest and passion for improving access to convenient and affordable healthcare
Responsibilities
- Collaborate with, and provide strategic and legal advice to, various cross-functional teams, including the Clinical Strategy, Customer Success, and Revenue teams
- Support SmithRx’s regulatory compliance posture with various government regulatory agencies, including regarding SmithRx’s licensing status, periodic required regulatory filings, and regulator inquiries as necessary
- Review, analyze, and advise business leaders regarding new and existing federal and state laws and regulations applicable to SmithRx’s current and future products and services
- Work with the Clinical Strategy team to develop new products and services to deliver cost savings to SmithRx’s clients
- Work with the Revenue team and Commercial Counsel team to provide regulatory support in contract negotiations and drafting
- Proactively support SmithRx’s business functions, including its Pharmacy Network and Clinical Review teams, and maintain compliance with applicable laws and regulations in various jurisdictions
- Support SmithRx’s internal Compliance function, including drafting/revising internal policies and guidance for the business relating to compliance with applicable healthcare laws and regulations
- Act as a client-facing subject matter expert on healthcare regulatory matters
- Collaborate with and help manage outside healthcare counsel
- Effectively prioritize and manage additional ad-hoc requests and responsibilities across a spectrum of complex business, legal, and strategic issues
Benefits
- Highly competitive wellness benefits including Medical, Pharmacy, Dental, Vision, and Life Insurance and AD&D Insurance
- Flexible Spending Benefits
- 401(k) Retirement Savings Program
- Short-term and long-term disability
- Discretionary Paid Time Off
- 12 Paid Holidays
- Wellness Benefits
- Commuter Benefits
- Paid Parental Leave benefits
- Employee Assistance Program (EAP)
- Well-stocked kitchen in office locations
- Professional development and training opportunities
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