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.

As a patient centric organization that strives to deliver innovative medicines to meet unmet needs, we feel that it is critical to follow the safety guidelines defined by CDC and OSHA. We believe the COVID-19 vaccine is the best way to manage COVID risk to you, your colleagues, your family and our society. With that in mind, we are taking the essential step to ensure the safety of our employees during this health crisis by requiring all US employees, temporary workers, agency employees and independent contractors to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. In accordance with applicable law, individuals may seek an accommodation for medical or disability-related conditions or sincerely held religious beliefs.

The Director, Corporate Counsel Rare Disease will serve as the legal advisor to the U.S. Commercial, Patient Advocacy 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 role requires legal coordination of relationship with KKNA's collboration business partner. Additional responsibilities include managing corporate governance matters.

• 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 for a marketed Rare Disease product, across its lifecycle development. You will act as a subject matter expert and stay abreast of evolving healthcare legislation and regulations and the 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. HUBs, coupons, PAPs); and, other matters relevant to the development and commercialization of prescription drugs in rare disease.
• Serve as lead lawyer on Rare Disease cross-functional teams and committees including without limitation, franchise/brand team, promotional and scientific material review committee, social media committee, grant committee and publication committee.
• Review business materials (including brand plans, medical plans, strategic initiatives, training documents) requiring legal input and advise internal clients, partners and stakeholders on compliant strategies, plans and tactics.
• 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.
• Counsel on appropriate relationships and engagement with a variety of external parties, including healthcare professionals, patients, academic institutions, patient advocacy organizations, and payors.
• 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 and educate clients, partners and affiliates about current U.S. enforcement trends. Assist with investigations.
• 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.
• Support corporate governance activities for U.S. entities, including drafting board minutes, resolutions and ensuring timely state filings and adherence to The Delaware General Corporations Law and internal governance rules.

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)
• Strong knowledge of and experience advising on statutes, regulations, and guidance documents applicable to commercial operations and medical affairs' activities, including: research and interpretation of FDCA, regulations and guidance; 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
• Experience with investigations
• Strong contract and negotiating skills
• Familiarity with Delaware General Corporation Law and board governance
• Requires up to 10% overnight travel

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.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), which is located at 135 Route 202/206, Suite 6, Bedminster, NJ 07921 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller's data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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