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General Description:

BeOne is actively seeking a seasoned compliance leader at the director level who thrives in fast-paced settings, brings a proactive, pragmatic approach to risk management, and is driven to make an impact. This role will report to the Senior Director, Global Compliance Program Office and will play a critical role in leading BeiGene’s Compliance auditing and monitoring program across North America, Europe, New Markets, and APAC.

In this role, you will develop and implement a compliance auditing and monitoring plan to address key risks, tailoring it to regional needs. You’ll conduct monitoring activities, collaborate with teams and vendors, and present progress to leadership. Responsibilities include managing compliance tools, analyzing data for trends, and enhancing programs to meet emerging risks and regulations. You’ll also lead Compliance investigations, maintain policies, and build strong relationships to navigate complex stakeholder interactions. This role requires integrity, strategic decision-making, and a commitment to ethical practices.

This position will be in the United States, either remote or at BeiGene’s offices in San Carlos, CA, Hopewell, NJ, or Cambridge, MA.

Essential Functions of the Job:

+ Partner with regional Compliance teams in North America, Europe, New Markets, and APAC to identify key Compliance risk areas for promotional and non-promotional activities and lead the design of annual compliance auditing and monitoring plans in Ex-China regions to address identified risks.

+ Size Compliance Audit and Monitoring program in Ex-China regions appropriately to meet the needs of each region based on maturity and volume of activities.

+ Conduct virtual, live, and retrospective monitoring.

+ Collaborate with colleagues and vendors as necessary to deliver the annual auditing and monitoring plan.

+ Partner with regional Compliance teams in North America, Europe, New Markets, and APAC to present progress of auditing and monitoring plan quarterly to Legal and Compliance leadership and regional compliance committees.

+ Collaborate with cross functional team members to gather the necessary information to support auditing and monitoring activities.

+ Manage, continue to evolve, and expand the auditing and monitoring technology platform and other supporting tools to support needs of all Ex-China regions.

+ Identify areas to enhance the auditing and monitoring program to meet emerging risk areas, current regulations, and industry trends.

+ Analyze and monitor compliance data and metrics to identify trends and assess the effectiveness and efficiency of monitoring activities and implement corrective actions, as needed.

+ Develop and maintain policies and SOP documentation to support the auditing, monitoring, and Compliance investigations programs.

+ Directly lead, oversee, or assist with Compliance investigations, as needed.

+ Ensure Compliance investigations align with legal, regulatory and company policies.

+ Cross-functional collaboration with Human Resources, Legal, Finance, Internal Audit, etc.

+ Apply strong personal and business acumen to build strong relationships at all levels in the organization and to navigate and manage complex stakeholder interactions effectively.

+ Demonstrate expertise in engaging with senior leaders on sensitive and complex issues.

+ Strategic and pragmatic approach to Compliance investigations, including the ability to make timely decisions in ambiguous situations with limited information.

+ Impeccable integrity, solid judgment, discretion, and finesse in handling sensitive matters/information.

+ Lead other ad-hoc reviews, inquiries, and investigations as required.

+ Lead and support other compliance initiatives as required.

+ Perform live monitoring (as needed) with domestic travel up to 20%.

Education Required:

+ Bachelor’s degree

Required Qualifications:

+ Bachelor of Arts or Bachelor of Science required; J.D. or other advanced degree preferred but not required.

+ BA/BS with 10 + years of overall experience, 7 + years of combined experience in healthcare compliance, including in-house experience.

+ Strong expertise in compliance with laws, regulations, and industry codes relevant to the development and commercialization of pharmaceutical products.

+ Working knowledge and experience with U.S. healthcare fraud and abuse laws (e.g., Anti-kickback statute, False Claims Act), FDCA, FDA guidance, OIG Compliance Program Guidance, OIG advisory opinions, and federal and state transparency and compliance program disclosure laws, and U.S. and international industry codes (e.g., PhRMA, EFPIA, IFPMA).

+ Experience as a Compliance business partner, working directly with business teams to advise on compliance issues and implement compliance initiatives with both home office and field teams.

+ Experience leading a compliance monitoring program and executing in-person as well as transactional activity reviews.

+ Excellent communication skills (oral and written; strong interpersonal skills in both one-on-one and group settings.

+ Ability to maintain a high degree of confidentiality in dealing with sensitive matters.

+ Acts with a sense of urgency, with high motivation and ability to take initiative, follow through and complete projects in a professional and expeditious manner.

+ Strong presentation skills, including creating and delivering presentations to various size audiences at all levels of the organization.

+ Strong analytical and problem-solving skills.

+ Strong attention to detail and accuracy.

+ Strong collaborative, interpersonal and oral communication skills.

Supervisory Responsibilities:

+ N/A

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.