Manager, Compliance Monitoring and Investigations

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Assist in the implementation of the global annual compliance monitoring program for all regions beyond Greater China.

• Oversee the annual monitoring program for North America, specifically the United States and Canada.

• Establish annual monitoring objectives and allocate monitors according to geography, availability, experience, and program requirements.

• Monitor checklists, observations, remediation efforts, corrective actions, and follow-up activities.

• Facilitate stakeholder meetings to discuss monitoring updates, observations, trends, and corrective action strategies.

• Execute virtual, live, and retrospective monitoring activities.

• Assist with region-specific monitoring strategies outside North America by engaging stakeholders, tracking progress, and conducting follow-ups.

• Improve the monitoring program's framework, which includes methodology, checklists, templates, training materials, and onboarding resources.

• Contribute to the global whistleblower and compliance investigations program for all regions outside Greater China.

• Aid investigations by reviewing documents, conducting interviews, and analyzing disciplinary review committee materials and investigation reports.

• Lead designated compliance investigations with integrity, discretion, consistency, and confidentiality.

• Maintain the case management system.

• Assist in evaluating conflicts of interest disclosures and recommend guidelines or conditions.

• Support third-party partner management, ensuring quality oversight and follow-up on deliverables.

• Define and uphold program metrics while analyzing data for patterns, trends, and emerging risks.

• Escalate significant observations or trends and suggest modifications to monitoring plans or controls.

• Develop and maintain dashboards and quarterly reports for compliance committees, the Audit Committee, leadership, and stakeholders.

• Preserve systems, policies, procedures, work instructions, templates, and other program-related documentation.

• Conduct live monitoring as necessary, with domestic travel up to 20%.

• Report directly to the Director of Compliance Monitoring and Investigations.

⛳️ Requirements

• A Bachelor’s degree is required.

• A minimum of 5 years of combined experience in healthcare compliance, auditing, monitoring, investigations, internal audit, or a related field.

• Familiarity with laws, regulations, and industry codes pertinent to pharmaceutical product development and commercialization.

• Knowledge and experience with U.S. healthcare fraud and abuse laws, FDCA, FDA guidance, OIG Compliance Program Guidance, OIG advisory opinions, and federal and state transparency and compliance program disclosure laws.

• Understanding of U.S. and international industry codes, including PhRMA, EFPIA, and IFPMA.

• Experience in supporting or managing risk-based compliance monitoring programs, which include live and transactional activity reviews.

• Experience in supporting or conducting internal investigations.

• Ability to coordinate multiple workstreams, stakeholders, vendors, deadlines, and corrective action plans in a global, matrixed environment.

• Capable of exercising sound judgment, maintaining confidentiality, and managing sensitive matters with integrity and discretion.

• Excellent written and verbal communication skills.

• Strong analytical and problem-solving abilities, including data interpretation, trend identification, and translating findings into actionable recommendations.

• Exceptional organizational skills, attention to detail, initiative, and follow-through.

• A collaborative interpersonal style with the ability to build effective relationships.

• Proficiency in 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 while managing sensitive information in accordance with legal, regulatory, and company requirements.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k).

• FSA/HSA.

• Life Insurance.

• Paid Time Off.

• Wellness program.