DescriptionThis role provides expert Legal advice to the business on a wide range of activities within a highly regulated environment. This role is responsible for providing legal support to the Market Access function within BioMarin, including Pricing, Access, Value, and Evidence which supports, Managed Markets, Pricing, Government Pricing, Patient Support and related functions. The ideal candidate will have prior experience counseling prescription drug companies on legal issues relating to market access, government pricing, contracting, federal and state laws impacting pricing and access, antitrust, state pricing transparency patient assistance, brand strategy and product commercialization activities.
Key Responsibilities- Advise business partners on various Commercial initiatives in a way that advances the company's strategy while addressing legal risks and protecting the company's integrity and reputation
- Provide legal advice and counsel on:
- Statutory and regulatory obligations under Medicaid, Medicare, 340B program, Veterans Health Care Act
- Market access and reimbursement issues
- Government pricing, including price reporting compliance policies and reasonable assumptions documents
- Centers for Medicare and Medicaid final rules and correspondence including letters and public comments on proposed rules and guidance
- Proposed and enacted United States federal and state legislation impacting pharmaceutical companies relating to market access, pricing, reimbursement as well as state drug price reporting and transparency laws and compliance
- Services and contracting relating to specialty distributors and specialty pharmacies
- Data and special projects
- Brand strategic planning and business operation plans
- Staying abreast of evolving healthcare legislation and regulations and the enforcement landscape
- Provide legal counsel and strategic support for the development, negotiation, interpretation, and administration of a broad range of pharmaceutical commercial contracts and arrangements with customers including:
- Commercial and government payers
- Pharmacy Benefit Managers (PBMs)
- Group Purchasing Organizations (GPOs)
- Specialty pharmacies and distributors
- Wholesalers and distribution partners
- Integrated Delivery Networks (IDNs)
- Health systems and provider organizations
- Patient support and patient services vendors
- Review, draft, and negotiate rebate agreements, value-based and outcomes-based agreements, administrative service agreements, distribution agreements, data licensing agreements, patient support agreements, and other market access-related contracts.
- Ensure compliance with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations
- Collaborate with Legal and Compliance colleagues to ensure delivery of comprehensive legal advice
- Participate in Medical Legal Review to provide guidance regarding external messaging
- Review and counsel on product labeling, promotional claims, comparative claims, health economic information, scientific exchange activities, and communications regarding clinical data, as necessary
- Contribute to the Legal & Compliance Department
- Participate in various Legal & Compliance Department projects and initiatives, including committees such as Culture and Pro Bono & Community
- Share information and knowledge through group presentations and individual discussions with peers and managers
Qualifications, Professional Skills, and Preferred Experience
- JD from an ABA accredited law school
- Member of a state bar
- Minimum of 8 years post-JD experience advising on legal matters in a life sciences space, whether in a law firm or in-house in the biopharmaceutical industry, or both
- Government price reporting experience
- Familiarity with health economic and outcomes research (HEOR), value communications, and market access promotional considerations is preferred.
- Strong ability to provide practical, business-oriented legal advice in a highly regulated environment while balancing legal, regulatory, reputational, and commercial considerations.
- Experience advising on statutes, regulations, and guidance documents applicable to market access activities, including Medicaid, 340B program, Veterans Administration, federal and state anti-kickback statutes, state drug pricing transparency laws, OIG guidance documents and advisory opinions, the False Claims Act, and the PhRMA Code
- Significant experience advising on pharmaceutical customer contracting across a broad range of stakeholders, including commercial and government payers, Pharmacy Benefit Managers (PBMs), Group Purchasing Organizations (GPOs), specialty pharmacies, specialty distributors, wholesalers, Integrated Delivery Networks (IDNs), and healthcare providers.
- Demonstrated experience drafting, reviewing, negotiating, and counseling on complex market access, rebate, distribution, administrative services, data, patient support, and value-based contracting arrangements.
- Outstanding ability to effectively communicate (verbally and in writing), sound legal advice to lawyers and non-lawyers alike, coupled with a strong understanding of business needs
- Excellent analytical, problem-solving and organizational skills to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards
- Ability to effectively and efficiently manage outside counsel and adhere to a budget
- Experience providing legal advice on specialty medicines is highly desired
- Enjoys working collaboratively and cross-functionally on teams, as well as independently
- Proactively solves problems and makes decisions with integrity and ethics
- Thrives in a fast-paced and dynamic environment
- Is eager to take on new challenges
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
