Compliance Lead, Japan

About us

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne , please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).

BeOne 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:

BeOne is seeking a compliance professional to help lead the Healthcare Compliance programs in Japan (and potentially other markets in region). Reporting to 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 BeOne therapies while at the same time 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 the Japan Leadership team to integrate appropriate healthcare, corporate and other compliance controls to guide the Company’s operations. The position will be based in Japan.

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

Supervisory Responsibilities: N/A

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 developing compliance programs Japan; Deep understanding and operational experience in Japan laws, regulations and industry codes (e.g., JPMA, JFTC) is a mandatory requirement; Experience in compliance in other APAC regions, is consider 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!)

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!

BeOne 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