Director, Corporate Counsel

2 days ago

Princeton, New Jersey, United States Kyowa Kirin, Inc.- U.S. Full time

About the Role:

The Director, Corporate Counsel – Rare Disease will serve as the legal advisor to the US Commercial, Patient Advocacy, Public Affairs, Regulatory, and Medical Affairs teams supporting our Rare Disease Franchise. This is a hybrid role, requiring at least two (2) days a week in our Princeton, NJ office.

Key Responsibilities:

  • Advise business partners on various Commercial, Patient Advocacy, Public Affairs, and Medical Affairs initiatives in a way that advances the Company's strategy while addressing legal risks and protecting the company's integrity and reputation.
  • Provide solution-oriented legal support on all aspects of a commercial business, including lifecycle management, for a marketed Rare Disease product.
  • Act as a subject matter expert and stay abreast of evolving healthcare legislation, regulations, and enforcement, enabling the provision of sound legal advice.
  • Review business materials (e.g., brand plans, medical plans, strategic initiatives, training documents) requiring legal input and advise internal clients, partners, and stakeholders on compliant strategies, plans, and tactics.
  • Counsel on appropriate relationships and engagement with a variety of external parties, including healthcare professionals, patients, academic institutions, patient advocacy organizations, and payors.
  • Issue guidance related to the reimbursement landscape in the U.S., with emphasis on the Inflation Reduction Act, government pricing regulations, and industry issues, such as co-pay accumulators and maximizers.
  • Work collaboratively with Compliance colleagues to develop and implement training to internal clients, partners, and stakeholders on key policies, procedures, and requirements for healthcare compliance.
  • Collaborate with other franchise attorneys and assist with special projects and contracting across franchises as workload necessitates.
  • Ability to manage and mentor junior attorneys and paralegals/contract managers.

Requirements:

  • J.D., License in good standing to practice law in New Jersey (including NJ limited in-house license to practice law).
  • Seven or more years practicing law. Previous in-house or outside counsel experience supporting commercialized rare or ultra-rare disease product(s) preferred.
  • Strong knowledge of and experience in advising on statutes, regulations, and guidance documents applicable to commercial operations and medical activities, including, the FDCA, its regulations and FDA guidance documents; federal and state anti-kickback statutes; OIG guidance documents and advisory opinions; the False Claims Act; and the PhRMA Code.
  • Experience in providing legal support for patient services, specifically internal HUB operations.
  • Experience on promotional review committees.
  • Strong contract and negotiating skills.
  • Technical Skills Proficient in MS Office Suite.

About Kyowa Kirin, Inc. - U.S.:

Kyowa Kirin, Inc. - U.S. is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology, and CNS/movement disorders. The North America organization includes three offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization.

Equal Employment Opportunity:

Kyowa Kirin, Inc. - U.S. is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.

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