Legal & Compliance Head, Canada

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 disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary of Job:

The Legal & Compliance Head, Canada will be a key senior team member supporting Kyowa Kirin North America’s (KKNA) 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 & Compliance 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, marketing and distribution of its products in Canada.  As such, the duties will include operational strategic advice, contract review, and partnering with company stakeholders (such as Market Access, Medical Affairs, Patient Advocacy & Government Affairs, Marketing, Sales, Clinical Operations, Distribution, Supply Operations, Quality, Regulatory, Pharmacovigilance, Patient Services and Human Resources) to ensure legal compliance and risk management of all Canadian activities. The Legal & Compliance Head, Canada will support the General Manager of KKCA and other regional leaders 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

Essential Functions:

• Establish and manage Canadian legal operations including governance, risk management, commercial operations, employment matters, pricing, and healthcare compliance in accordance with local, provincial, territorial, and federal laws.
• 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.
• Provide legal support for the advertising and marketing of medicines, including through Promotional Review Committee, and scientific exchange activities through the Medical Review Committee.
• 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.
• Partner with all business departments within the company to support the drafting and negotiation of all agreements, within KKNA’s electronic contract management system, including but not limited to: Commercial, Sales & Marketing, Market Access, Medical Affairs, Patient Advocacy, Public Affairs, Quality, Business Development, Supply Operations, and Clinical Operations/Research and Development. Interact with all relevant Federal and Provincial Gov’t bodies on regulatory matters as needed. 
• 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.
• Provide guidance and advise to Human Resources to ensure company compliance with Canadian employment and other laws.
• Provide legal support for any necessary crisis management related to Canadian operations.
• Serve as Canadian legal representative in cross-regional global teams, such as Global Labelling Committee, and educate regional and global team members on Canadian laws and regulations, provide feedback on regional and global internal and external documents and initiatives, and be responsible for incorporating regional and global compliance initiatives in Canada.
• Collaborate with the Senior Director, Privacy and Commercial Counsel to ensure compliance with applicable privacy laws impacting Canadian operations.
• 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.
• Oversee and manage outside legal counsel as needed to ensure timely, effective and cost-effective legal advice in support of the organization.
• Oversee and effectively manage any litigation engaging Canadian operations.
• Responsible for ensuring timely and effective filing of all required federal, provincial, and territorial, documents required to operate a pharmaceutical business in Canada.
• Support corporate governance including maintaining corporate records books, and drafting laws, resolutions, and minutes.
• 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.
• Identify emerging risks and quickly adapt the Company’s activities to respond to emerging trends and risks.
• 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.
• Develop and manage legal and compliance budgets for Canadian legal and compliance operations.

Job Requirements:

Education

JD/LLB degree and member in good standing in a Canadian bar required. 

 

Experience

10 years of broad experience in the legal and pharmaceutical and/or medical device industry, either as inside or outside counsel. 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. 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.

Physical Demands: Normal office environment with prolonged sitting and extensive computer work

Working Conditions: Requires up to 15% domestic and international travel

 

The anticipated salary for this position will be $280,000 CAD to $290,000 CAD.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

 

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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