Kyowa Kirin 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. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.
Summary of Job:
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, and will coordinate legal services with the attorney responsible for Canadian support for the Rare Disease Franchise.
This is a hybrid role, requiring at least two (2) days a week in our Princeton, NJ office.
Essential Functions:
- 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. You will be a key member of the North American Legal team.
- Provide solution oriented legal support on all aspects of a commercial business, including lifecycle management, for a marketed Rare Disease product. You will act as a subject matter expert and stay abreast of evolving healthcare legislation, regulations, and enforcement, enabling the provision of sound legal advice. You will be responsible for advising on matters relating to the Food, Drug, and Cosmetic Act (FDCA) and its regulations; advertising and promotion strategies and activities; dissemination of scientific information; product development and labeling; market access initiatives; healthcare fraud and abuse; distribution of drugs; patient engagement and advocacy; patient services/support programs (e.g. coupons, PAPs); and other matters relevant to the development and commercialization of prescription drugs.
- Serve as lead lawyer on Rare Disease cross-functional teams and committees, including without limitation, the franchise/brand team, the promotional and scientific material review committees, the social media committee, the grant committee, and the publication committee.
- 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. preferred, 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. Educate clients, partners, and affiliates about current U.S. enforcement trends.
- 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.
- Partner with internal clients to identify and understand their business requirements and negotiate contracts in accordance with those requirements and the Company’s overall objectives and policies.
Job Requirements
Education
J.D., License in good standing to practice law in New Jersey (including NJ limited in-house license to practice law).
Experience
- 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.
Non-Technical Skills
Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic. Detail oriented and excellent follow through. Ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Maintain a passion for personal learning and development. Understand cultural sensitivity and exercise the ability to develop consensus within a multinational organization.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions.
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
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Recruitment & Staffing Agencies
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