The posting
Job Title: Manager, Compliance Monitoring and Investigations
Job Location: Remote (US)
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
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.
General 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. You will also support the global whistleblower and investigations program through document review, interviews, case management, committee materials, and case reporting, and will 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.
Essential Functions of the Job:
- Support execution of 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 North America annual monitoring program for the United States and Canada, including defining annual monitoring targets based on established criteria and methodology.
- Identify activities eligible for monitoring and assign monitors based on geography, availability, experience, and program needs.
- Track completion of monitoring checklists, observations, remediation, corrective actions, and other follow-up activities; support remediation through completion where required.
- Conduct regular stakeholder meetings to review monitoring progress, observations, trends, and defined corrective action plans.
- Conduct virtual, live, and retrospective monitoring activities as assigned.
- Support region-specific monitoring plans for markets outside North America through stakeholder engagement, progress tracking, and follow-up on monitoring goals.
- Identify and implement opportunities to enhance program infrastructure, including monitoring methodology, checklists, communication templates, training materials, and onboarding resources for monitors.
- Support the global whistleblower and compliance investigations program for all regions outside of Greater China.
- Support investigations through document review, investigative interviews, preparation of disciplinary review committee materials, and drafting of investigation reports.
- Lead compliance investigations as assigned and ensure investigative activities are conducted with integrity, discretion, consistency, and appropriate confidentiality.
- 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%.
Required 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.
Supervisory Responsibilities:
- N/A
Computer Skills: Microsoft 365 applications; case management and compliance monitoring systems; data visualization and dashboard tools; advanced Excel and reporting tools; SharePoint; collaboration or project-management platforms.
Other Qualifications: Ability to work across regions and time zones and to manage sensitive information in accordance with legal, regulatory, and company requirements.
Travel: Domestic travel up to 20%.
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, 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
Salary Range: $133,400.00 - $173,400.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].
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