Manager, Compliance Monitoring and Investigations

BeiGene

3d•$133,400 - $173,400

About The Position

BeOne is seeking an experienced compliance professional at the manager level to support execution of the global annual compliance monitoring program for all regions outside of Greater China, with primary responsibility for the North America program. The role coordinates risk-based monitoring plans, assigns and tracks monitoring activities, engages regional and cross-functional stakeholders, analyzes program data, and supports remediation through completion. The position also supports the global whistleblower and investigations program through document review, interviews, case management, committee materials, and case reporting, and leads investigations as assigned. It reports to the Director, Compliance Monitoring and Investigations. The role is based in the United States and may be remote or located at BeOne offices in San Carlos, California; Hopewell, New Jersey; or Cambridge, Massachusetts. Domestic travel of up to 20% is required as needed for live monitoring.

Requirements

Bachelor's degree.
At least 5 years of combined experience in healthcare compliance, auditing, monitoring, investigations, internal audit, or a related field.
Working knowledge of laws, regulations, and industry codes relevant to pharmaceutical product development and commercialization.
Working knowledge and experience with U.S. healthcare fraud and abuse laws, including the Anti-kickback Statute and False Claims Act; FDCA; FDA guidance; OIG Compliance Program Guidance and advisory opinions; federal and state transparency and compliance program disclosure laws; and U.S. and international industry codes such as PhRMA, EFPIA, and 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.
High motivation, initiative, urgency, and ability to follow through and complete projects professionally and expeditiously.
Excellent written and verbal communication skills and ability to present information clearly to varied audiences.
Strong analytical and problem-solving skills, including interpreting data, identifying trends, and translating findings into practical recommendations.
Strong organizational skills, attention to detail, initiative, and ability to follow through in a fast-paced environment.
Collaborative interpersonal style and ability to build effective relationships with colleagues.
Computer skills with Microsoft 365 applications, case management and compliance monitoring systems, data visualization and dashboard tools, advanced Excel and reporting tools, SharePoint, and collaboration or project-management platforms.
Ability to work across regions and time zones and manage sensitive information in accordance with legal, regulatory, and company requirements.

Nice To Haves

Pharmaceutical or biotech industry experience.

Responsibilities

Support the global annual compliance monitoring program for all regions outside of Greater China, including live and transactional monitoring activities and country-specific risk assessments.
Manage the annual North America monitoring program for the United States and Canada, including setting monitoring targets using established criteria and methodology.
Identify activities eligible for monitoring and assign monitors based on geography, availability, experience, and program needs.
Track monitoring checklists, observations, remediation, corrective actions, and follow-up activities, and support remediation through completion.
Conduct regular stakeholder meetings to review monitoring progress, observations, trends, and corrective action plans.
Conduct virtual, live, and retrospective monitoring activities as assigned.
Support region-specific monitoring plans outside North America through stakeholder engagement, progress tracking, and follow-up.
Identify and implement improvements to program infrastructure, including methodology, checklists, communication templates, training materials, and monitor onboarding resources.
Support the global whistleblower and compliance investigations program for all regions outside of Greater China.
Support investigations through document review, investigative interviews, disciplinary review committee materials, and investigation report drafting.
Lead assigned compliance investigations, ensuring integrity, discretion, consistency, and appropriate confidentiality.
Maintain accurate and current records in the case management system.
Support evaluation of conflicts of interest disclosures and recommend 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 program metrics and analyze data to identify patterns, trends, and emerging risks.
Escalate significant observations or trends and recommend changes to monitoring plans or program controls.
Help create and maintain dashboards and quarterly reports for compliance committees, the Audit Committee, leadership, and other stakeholders.
Maintain systems, policies, procedures, work instructions, templates, and other documentation supporting monitoring and investigations programs.
Support other compliance initiatives as required.
Perform live monitoring as needed, with domestic travel up to 20%.

Benefits

Medical insurance
Dental insurance
Vision insurance
401(k)
FSA/HSA
Life insurance
Paid time off
Wellness program
Annual bonus plan eligibility for non-commercial roles or incentive compensation plan eligibility for commercial roles
Eligibility for discretionary equity awards
Voluntary participation in the Employee Stock Purchase Plan