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Director, Corporate Counsel Rare Disease
Refer job# QVGL172415
 
Salary Competitive salary and benefits package Kyowa Kirin North America is seeking a Director, Corporate Counsel Rare Disease to join the North America Legal Team. 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 collaboration business partner. Job Title: Director, Corporate Counsel Rare Disease Location: Princeton, New Jersey Salary: Competitive salary and benefits package Job Description: Kyowa Kirin North America is seeking a Director, Corporate Counsel Rare Disease to join the North America Legal Team. 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 collaboration business partner. The Director, Corporate Counsel Rare Disease will be responsible for: * Advising 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. * Providing solution oriented legal support on all aspects of a commercial business for a marketed Rare Disease product, across its lifecycle development. * Acting as a subject matter expert and staying abreast of evolving healthcare legislation and regulations and the enforcement, enabling the provision of sound legal advice. * 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. * Serving 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. * Reviewing 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. * Partnering 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. * Counseling on appropriate relationships and engagement with a variety of external parties, including healthcare professionals, patients, academic institutions, patient advocacy organizations, and payors. * Working 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. Assisting with investigations. * Collaborating with other franchise attorneys and assist with special projects and contracting across franchises as workload necessitates. * Managing and mentoring junior attorneys and paralegals/contract managers. * Supporting 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. Qualifications: * 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) * 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 Kyowa Kirin North America is dedicated to providing innovative medicines to meet unmet needs and is committed to following the safety guidelines defined by the CDC and OSHA. The company is taking the essential step to ensure the safety of their employees during the COVID-19 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. Kyowa Kirin North America is offering a competitive salary and benefits package to the successful Director, Corporate Counsel Rare Disease. Job Summary Kyowa Kirin North America is seeking a Director, Corporate Counsel Rare Disease to join the North America Legal Team. The Director, Corporate Counsel Rare Disease will serve as the legal advisor to the U

J.D., License in good standing to practice law in New Jersey
 
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