Assistant General Counsel, Market Access
5 days ago
This position is responsible for independently providing innovative and strategic legal support and solutions as a market access attorney and the primary legal advisor for market access and contract and pricing departments supporting U.
S.
approved (or to be approved) products including, but not limited to, areas of GPO/PBM and trade/distribution agreements, Medicare, Medicaid, product pricing, and government price reporting.
Responsibilities: Lead drafting and negotiating contracts for commercial, Medicaid and Medicare coverage, as well as other government contracts, trade/distribution agreements, and contracting relative to specialty pharmacy and patient support services.
Provide advice and guidance on issues pertaining to best price, WAC, AMP, ASP, and federal and state price reporting.
Supervise external outside counsel.
Serve as a member of Labeling and Pricing Committees and as legal representative on the promotional materials review team for market access team and materials (including, but not limited to, patient programs, patient support hub services, call center operations, reimbursement assistance and expanded use programs, PIE, FDAMA 114 and healthcare economics initiatives) on an as-needed basis.
Liaise with Government Affairs colleagues on proposed and enacted laws relating to pricing, Medicaid, Medicare, and other market access matters and issues.
Monitor current developments in several key legal areas and provide Senior Management and other business leaders with updates regarding same (including Legal Affairs Department colleagues).
Work collaboratively with Compliance colleagues to develop and implement training to internal clients, partners, and stakeholders on key policies, procedures, practices, and requirements for healthcare and related legal compliance and educate clients and partners about current enforcement trends.
Qualifications: Bachelor's Degree required.
JD from Law School of recognized standing, and Bar Admission in NJ (direct admission or eligible for limited in-house licensing in NJ) required.
Admission to practice in the U.
S.
Patent Office required.7 or More Years of post-law school experience required.7 or More Years experience in regulatory, compliance, and legal matters relating to pricing and Market Access (including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the Ph RMA Code, and product liability laws) required.7 or More Years Pharmaceutical industry experience, particularly supporting specific assigned products and business areas in contracting, general legal advice, policy development and/or review, etc.
in specific business support functions in an in-house capacity, as a legal consultant, and/or at a law firm in a practice group focusing on pharmaceutical industry and/or specific corporate business functions required.
Experience with pricing and Market Access required.
Experience with Veeva Vault Promo Mats preferred.
Experience with investigational products, product promotion, scientific exchange, and disease state communications preferred.
Experience with Government Affairs preferred.
Physical Requirements: Ability to travel up to 20% (Travel to Japan 3-4 times per year required).
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