Senior Director, Senior Counsel

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 two 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: 

Lead commercial attorney providing coordinating legal and strategic  support across North American commercial franchises and global commercial franchises as needed.

Essential Functions: 

• Serve as the Senior commercial attorney responsible for managing commercial attorneys and coordinating legal positions on various issues governing late-stage investigational products and marketed prescription products.
• Coordinate with Canadian Legal Head as necessary on US legal positions governing commercial activities and Sr. Counsel Privacy North America to ensure integration of North American privacy laws and regulations in commercial activities.
• KKNA Legal representative to Global Medical Affairs and Global Franchise teams for review of policies and systems implementations for compliance with US laws and regulations to the extent such policies and systems affect KKNA activities. 
• Responsible for creation of training materials and training schedule on legal requirements for commercialization activities for branded products for third party vendors and franchise team members (coordinate with Regulatory as needed). Responsible for development and delivery of additional legal training to various internal and external stakeholders as requested by the General Counsel.
• Support ad hoc policy development for commercialization of branded products as requested by the General Counsel.
• Responsible for scheduling, planning and maintaining records for the monthly all attorney meeting.
• Global legal representative for commercialization activities related to investigational products as requested by General Counsel, including providing legal support for the establishment of review processes and policies with collaboration partners as applicable and as directed by global team lead.
• Support departmental projects as requested by the General Counsel.
• Support global projects governing commercialization activities that require U.S. legal review as requested by the General Counsel.

Job Requirements:

Education

JD required.

 Experience

• Minimum 10 years legal experience (in-house experience in life sciences’ industry preferred)
• License in good standing in New Jersey to serve as in-house counsel
• Strong analytical abilities, leadership qualities, communication and negotiation skills
• Strong knowledge of: federal and state healthcare fraud and abuse knowledge including, Anti-kickback statute, FDA advertising and promotional laws and regulations, Federal False Claims Act; and FTC consumer protection laws.

Technical Skills

• Microsoft Office
• Ability to work in contract management system

Non-Technical Skills

• Excellent leadership, interpersonal, and communication skills. Strong analytical, decision-making, and problem-solving skills. Innovative and entrepreneurial mindset, motivational abilities, and the ability to find and retain talented employees. Working in a multi-cultural environment. Cultural sensitivity and ability to develop consensus within a multinational organization. Ability to collaborate cross functionally and provide strategic advice in a practical and understandable manner. Ability to manage a team.

 

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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