Compliance Lead, Japan

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description:

General Description:

• BeiGene is seeking a compliance professional to lead the Healthcare Compliance programs in Japan (and potentially other markets in region). Reporting to the Head of Compliance, APAC, this is an excellent opportunity to serve as the primary interface for Japan commercial organizations to support the launch of new BeiGene therapies while contributing to the company’s geographic expansion in those markets. The position will contribute to the development and implementation of organizational strategies, policies and practices, and work with Commercial, Medical, Clinical Development, Finance and HR leadership to integrate appropriate healthcare, corporate and other compliance controls to guide the Company’s operations. The position will be based in Tokyo.

Responsibilities:

• Support the continued development of the Japan Healthcare Compliance Program in line with the OIG Compliance Program Guidance for Pharmaceutical Manufactures (OIG Guidance), applicable industry codes (including but not limited to, JPMA code, JFTC etc.) and best practices.
• Proactively identify legal and regulatory issues, industry trends, industry codes and practices applicable to Healthcare Compliance; and advise on the adoption of new, or revision of existing, policies and procedures to ensure the continued effectiveness of the Company’s Healthcare Compliance Program.
• Assess the potential impact of Commercial, Medical, Clinical Development and other initiatives to the Company’s Healthcare Compliance Program and support the design of policies, procedures, processes and/or systems, including but not limited to HCP fair market value methodology and third-party risk management, to manage identified risk areas.
• Establish policies, procedures, and systems to foster compliance with healthcare fraud and abuse, privacy, and transparency reporting obligations, as well as applicable industry codes in the region.
• Develop and monitor the execution of a comprehensive compliance training program for Japan employees and designated third parties on applicable healthcare compliance policies, laws and regulations, including any new developments or updates that may impact the Healthcare Compliance Program.
• Provide compliance leadership and oversight for review and approval processes for core Commercial and Medical activities: grants, sponsorships, speaker bureau, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations and patients/advocacy groups.
• Collaborate with other functions on the design and execution of internal reviews, risk assessments, monitoring and auditing to ensure that compliance policies and procedures function as intended and the Company identifies potential compliance risks and remediates where necessary.
• Partner with internal (e.g., Legal and Human Resources) and external (e.g., outside counsel or investigators) stakeholders for the conduct and resolution of potential compliance investigations, including the management of any resulting corrective actions plans.
• Institute and maintain effective compliance communication channels for the Company by promoting awareness and retention of the Code of Conduct, the use of the Compliance Helpline, as well other means for employees to report compliance-related concerns or engage with senior leadership.
• Provide regular healthcare compliance related reports, presentations and other communications for multiple audiences in the Company, including Commercial and Medical Affairs teams, country / regional management teams and Compliance Committee.
• Develop, manage, and execute an annual Compliance Workplan, including functional objectives, strategic priorities, and operating budget.
• Assume the role of the designated Data Protection Officer in charge of Personal Information Protection for Japan, when necessary and as aligned with Privacy and Data Ethics Office.

Qualification Required:

Education Required:

• Bachelor’s degree in business; Risk Management or Law required; Advanced relevant graduate degree preferred.
   

Computer Skills:

• Proficiency in the Microsoft suite of tools including Outlook, Word, PowerPoint and Excel.

Other Qualifications and Experience:

• Minimum of 8 - 10 years combined relevant experience and education including in-house pharmaceutical experience in developing compliance programs in Japan; A deep understanding and operational experience with Japan laws, regulations, and industry codes (e.g., JPMA, JFTC) are mandatory requirements; Experience in compliance in other APAC regions is considered a plus. 
• Extensive experience with compliance matters relating to the development, approval, and commercialization of pharmaceutical products.
• Ability to apply a risk-based analysis to compliance issues and demonstrate creativity and flexibility in developing solutions that satisfy both business requirements and legal obligations.
• Strong critical thinking skills, attention to detail, adaptability, communication skills and professionalism.
• Ability to work in a matrix organization, collaborate with business partners, influence peers, and interact with both senior management and cross functional teams from Sales, Medical, Clinical, Finance, HR and Legal.
• Ability to manage and serve a wide range of client groups by recognizing and responding quickly and pragmatically to urgent situations.
• Exceptional and demonstrated written and verbal communication skills and interpersonal skills in both one-on-one and group settings, as well as proven negotiation skills.
• Excellent organizational skills and problem-solving capabilities and the ability to perform in a fast-paced, high volume, deadline-driven environment.
• Confidence to advise clients at all levels with little oversight.
• Appropriate judgment to liaise with Legal and business colleagues and/or outside counsel as needed.
• Commitment to being a team player with the desire to be helpful in other areas covered by a growing Compliance department.

Travel:

• This position requires some travel to maintain a high level of visibility with field teams, leadership and general presence at company events (e.g., scientific conferences, national and regional plan of action meetings).

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant and performance-based annual equity plan!)
• In-house and external learning and development opportunities
• Fantastic benefits program and keep improving!
• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
• Join us and Make momentum in your career!

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeiGene’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene’s Job Applicant Privacy Policy (https://www.beigene.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeiGene’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeiGene’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.