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Assistant General Counsel, Market Access

1 month ago

Bernards NJ United States Daiichi Sankyo, Inc. Full time

Join a Legacy of Innovation 110 Years and Counting

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.


Summary

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. Coordination with, and appropriate supervision of, outside counsel as is required. Provides appropriate counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor in order to foster their professional growth and development as well as their achievement of Company and/or departmental expectations and goals as identified by senior management.

Responsibilities

- Lead drafting and negotiating contracts for commercial, Medicaid and Medicare coverage, as well as other government contracts, trade/distribution agreements, as well as 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 provides Senior Management and other business leaders with updates regarding same (including Legal Affairs Department colleagues). Works independently and, as appropriate, in collaboration with other departments in developing, implementing and presenting training materials on various legal issues pertaining to assigned business areas. 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. Such training materials may be presented to functions supported by this position (or by them) but would also be available for use by the Legal Affairs Department generally.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

- 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

Experience Qualifications

- 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 PhRMA 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 PromoMats preferred
- Experience with investigational products, product promotion, scientific exchange, and disease state communications preferred
- Experience with Government Affairs preferred Licenses and Certifications

- Eligible to practice law in the state of New Jersey (either licensed in NJ or limited in-house license) and maintain such license in good standing at all times. required

Travel

Ability to travel up to 5%. Occasional travel required

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.