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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading compliance investigations and developing monitoring programs within the pharmaceutical industry, with a strong focus on regulatory compliance and risk management. Proven ability to collaborate with cross-functional teams and communicate effectively with senior leadership.
Highest-signal resume keywords
Juris Doctor (JD)Internal Compliance InvestigationsU.S. Healthcare CompliancePharmaceutical Industry RegulationsMonitoring Program Design
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Compliance InvestigationsData ReviewEvidence AssessmentMonitoring MethodologiesTrend IdentificationProject ManagementDocumentation StandardsRisk-Based MonitoringAnalytical SkillsCase Management
Soft Skills
Interpersonal SkillsCommunication SkillsInfluencing SkillsOrganizational SkillsCritical Thinking
Tools & Technologies
DashboardsReporting PackagesData-Driven AnalyticsMonitoring PlansTraining Programs
Industry Keywords
Pharmaceutical ComplianceFederal Anti-Kickback StatuteFalse Claims ActFDCAOIG/DOJ GuidancePhRMA CodeMarketing Compliance LawsLife SciencesBiotechnologyEthics and Accountability
About the role
Key responsibilities & impact- Lead the U.S. Compliance Investigations program and oversee its day-to-day operation
- Own the investigations program framework and coordinate with HR, Legal, Compliance Business Partners, and other stakeholders
- Establish intake, triage, scoping, documentation, and closure standards
- Conduct investigations, including data review, interviews, and evidence assessment
- Lead investigation readouts with senior leadership
- Recommend remediation and independently handle matters of varied complexity
- Interpret policies and implement remediation such as policy updates, training, coaching, and enhanced monitoring
- Develop investigations procedures, documentation, templates, guidance, and training
- Train cross-functional colleagues on investigations processes, documentation, and case management expectations
- Design and continuously improve the U.S. compliance monitoring program
- Build and execute risk-based monitoring plans covering field rides, speaker programs, advisory boards, trainings, congresses, and in-market promotional or educational events
- Refine monitoring methodologies and sampling
- Identify emerging risks, anomalies, and trends for transactional and data-driven monitoring and analytics
- Develop dashboards and reporting packages
- Deliver periodic monitoring reports to leadership and committees
- Support targeted reviews and promote a strong ethics and compliance culture
- Collaborate across teams through virtual and in-person meetings
Requirements
What you’ll need- Juris Doctor (JD) or in-house compliance investigations experience at a pharmaceutical or medical device company
- 8-12 years of experience advising a pharmaceutical, biotechnology, or life sciences company on compliance matters
- Significant experience conducting internal compliance investigations and managing investigations programs
- Expertise and significant experience advising on U.S. healthcare compliance for prescription products and devices
- Deep knowledge of pharmaceutical industry regulations and therapeutic areas
- Knowledge of the Federal Anti-Kickback Statute, False Claims Act, FDCA, OIG/DOJ guidance, PhRMA Code, U.S. state and local marketing compliance laws, and relevant enforcement actions
- Experience designing and executing monitoring programs, including field-based monitoring and data-driven analytics
- Strong commercial acumen and understanding of market dynamics and business culture impacts
- Excellent analytical and critical thinking skills, including large datasets, trend identification, and big-picture analysis
- Strong interpersonal, communication, and influencing skills
- Ability to work effectively with senior leadership and stakeholders at all levels
- Ability to manage multiple complex matters in a fast-paced environment
- Strong project management and organizational skills
- Ability to handle confidential information appropriately and exercise sound judgment on sensitive investigations and monitoring matters
- Demonstrated commitment to compliance, ethics, and accountability
- Ability to travel up to 30%
- Must be eligible to work in the United States
- This role does not offer sponsorship for work authorization
Benefits
Comp & perks- Annual short-term incentive program, subject to plan terms and eligibility requirements
- Medical, dental, and vision coverage
- 401(k) plan with employer match
- Paid time off
- Competitive compensation
- Comprehensive benefits
- Opportunities for growth, development, and collaboration
- Inclusive and innovative work environment
- Reasonable accommodations for individuals with disabilities
