Legal Head, Canada Jobs

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.

Summary of Job:

Reporting to the Executive Vice President, Chief Compliance Officer and General Counsel North America (located in New Jersey office), the Legal Head, Canada will be a key senior team member supporting KKNA’s rapid business growth in Canada and will be responsible for ensuring that such growth is achieved in accordance with applicable laws and aligned with KKNA’s global corporate values: Commitment to Life; Innovation; Integrity; and Teamwork/WA. The Legal Head, Canada will be responsible for the day-to-day legal needs for the Canadian operations of the company and the design, implementation, management and continuous advancement of the North American healthcare compliance program in Canada. The Company’s operations in Canada include the importation, sale and distribution of its’ products in Canada. As such, the duties will include contract review, working with company stakeholders (such as Medical Affairs, Commercial, Distribution, Supply Operations, Quality, Regulatory, Pharmacovigilance and Patient Services) to ensure legal compliance and risk management of all Canadian activities. The role will also be responsible for supporting Human Resources to ensure compliance with Canadian employment laws. The successful candidate will support the General Manager of KKCA in fostering the corporate vision and compliantly driving strategic initiatives while ensuring that the Canadian operations are operating in compliance with all applicable provincial, federal and international laws affecting Canadian activities. Additionally, the successful candidate will provide legal counsel and coordination with outside counsel and the broader North American Legal and Compliance teams for company initiatives, including coordination with the Senior Director, Privacy and Commercial Counsel to coordinate compliance with applicable privacy laws impacting Canadian operations.

Essential Functions:

• Actively engage with internal and external business partners to understand and provide legal guidance on the development and execution of proposed strategic and tactical initiatives.
• Interact with all relevant Federal and Provincial Gov’t bodies on regulatory matters as needed.
• Stay abreast of Canadian laws, regulations and enforcement activities related to the pharmaceutical industry, including active participation with the Canadian industry, and with applicable professional associations and any applicable international associations.
• Strong contract drafting skills in the pharmaceutical and/or biotech industry.
• Provide guidance on laws and regulations governing reimbursement of pharmaceutical products and drafting of legal documents required for the HTA bodies and pCPA, and public and private product listing agreements.
• Establish and manage Canadian legal operations including governance, risk management, commercial operations, employment matters, and healthcare compliance in accordance with local, provincial, territorial, and federal laws.
• Responsible for ensuring timely and effective filing of all required federal, provincial, and territorial, documents required to operate a Pharmaceutical business in Canada.
• Identify emerging risks and quickly adapt the Company’s activities to respond to emerging trends and risks.
• Partner with all business departments within the company to support drafting and negotiation of all agreements, within KKNA’s electronic contract management system, including but not limited to: Commercial, Sales & Marketing, Medical Affairs, Patient Advocacy, Public Affairs, Quality, Business Development, Supply Operations, and Research and Development.
• Serve as Canadian legal representative in cross regional global teams and educate global team members on Canadian laws and regulations, provide feedback on global internal and external documents and initiatives and be responsible for incorporating global compliance initiatives in Canada.
• Provide legal support for the Promotional and Medical Review Committees and responsible for interacting with PAAB as needed.
• Partner with the North American Compliance Team to regularly assess the effectiveness of the Canadian compliance program; overseeing periodic risk assessments and implementation of corrective action plans and assisting in auditing and monitoring processes to monitor related Canadian activities.
• Support corporate governance including maintaining corporate records books, drafting bylaws, resolutions and minutes.
• Demonstrated experience in leading cross-functional projects and balancing conflicting demands in a growing company.
• Provide legal support for any necessary crisis management related to Canadian operations.
• Develop and implement necessary legal and compliance policies and procedures to ensure compliance of operations in Canada under applicable local, provincial, territorial, and federal Canadian laws.

Job Requirements:

Education

JD/LLB degree and member in good standing in a Canadian bar required and a minimum of 10+ years of broad experience in the legal and pharmaceutical and/or medical device industry, either as inside or outside counsel.

A university degree in business and/or the life sciences is an asset.

Bilingualism in French and English is an asset. Deep understanding of Canadian laws, including health laws, including Food and Drugs Act and regulations, Patent Act and regulations, privacy and data protection laws, including PIPEDA (Canada), applicable industry and professional codes of conduct, such as IMC Code of Ethical Practices, PAAB, and those of the various professional governing bodies, reimbursement (including product listing agreements), pricing (including the PMPRB), patent linkage (PM(NOC) and data exclusivity and patent term extensions (CSPs), distribution and marketing laws

Experience

Demonstrated experience in leading cross-functional projects and balancing conflicting demands in a growing company. Strong contract drafting skills in the pharmaceutical and/or biotech industry. Experience with Digital Health Initiatives preferred.

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, and presentation skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Strategic and analytical thinker with strong business acumen and decision-making skills. Strong leadership skills, high integrity, strong work ethic, self-motivated, respectful, and conscientious. Has a passion for personal learning and development to be able to grow with the company. Must be able to execute on day-to-day tactical responsibilities effectively and independently while also implementing strategic imperatives that will move the organization to meet its’ business objectives in Canada. Cultural sensitivity and 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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