[Hiring] Manager, Compliance Monitoring and Investigations @BeiGene

Role Description

BeOne is actively seeking an experienced compliance professional at the manager level who brings a proactive, pragmatic, and detail-oriented approach to compliance monitoring and investigations. This role will report to the Director, Compliance Monitoring and Investigations and will support execution of the global annual compliance monitoring program for all regions outside of Greater China, with primary responsibility for managing the North America program.

In this role, you will:

• Coordinate risk-based monitoring plans.
• Assign and track monitoring activities.
• Engage regional and cross-functional stakeholders.
• Analyze program data and support remediation through completion.
• Support the global whistleblower and investigations program through document review, interviews, case management, committee materials, and case reporting.
• Lead investigations as assigned.

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

Qualifications

• Bachelor’s degree required.
• 5+ years of combined experience in healthcare compliance, auditing, monitoring, investigations, internal audit, or related field; pharmaceutical or biotech industry experience preferred.
• Working knowledge of 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 supporting or managing risk-based compliance monitoring programs, including live and transactional activity reviews.
• Experience supporting or conducting internal investigations.
• Experience coordinating multiple workstreams, stakeholders, vendors, deadlines, and corrective action plans in a global, matrixed environment.
• Ability to exercise sound judgment, maintain confidentiality, and handle sensitive matters with integrity and discretion.
• 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.
• Excellent written and verbal communication skills and the ability to present information clearly to varied audiences.
• Strong analytical and problem-solving skills, including the ability to interpret data, identify trends, and translate findings into practical recommendations.
• Strong organizational skills, attention to detail, initiative, and ability to follow through on commitments in a fast-paced environment.
• Collaborative interpersonal style and demonstrated ability to build effective relationships with colleagues.

Requirements

• Maintain the case management system to ensure information is accurate and current.
• Support the evaluation of conflicts of interest disclosures and recommend appropriate guidelines or conditions for approved disclosures.
• Assist with management of third-party support partners, including coordination, quality oversight, and follow-up on deliverables.
• Define and maintain meaningful program metrics and analyze data to identify patterns, trends, and emerging risks.
• Escalate significant observations or trends as appropriate and recommend adjustments to monitoring plans or program controls.
• Assist in creating and maintaining dashboards and quarterly reports for compliance committees, the Audit Committee, leadership, and other stakeholders.
• Maintain systems, policies, procedures, work instructions, templates, and other documentation that support the monitoring and investigations programs.
• Support other compliance initiatives as required.
• Perform live monitoring as needed, with domestic travel up to 20%.

Benefits

• Medical, Dental, Vision.
• 401(k), FSA/HSA.
• Life Insurance.
• Paid Time Off.
• Wellness programs.

Company Description

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.