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Associate Director, Compliance Operations

Associate Director, Compliance Operations

EisaiNutley, NJ, US
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Associate Director, Compliance Operations

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisais human health care mission. Were a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the worlds most widely-used treatment for Alzheimers disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

The Associate Director, Compliance Operations will be a key member of Eisais U.S. Ethics & Compliance team, responsible for implementing the execution and evolution of Eisais Compliance Monitoring Program. This role will oversee both live and transactional monitoring of interactions with healthcare professionals (HCPs), and will communicate findings to relevant business leaders to drive compliance awareness and improvement. This individual will serve as the primary point of contact for Eisais U.S. monitoring activities, managing in-house efforts and third-party vendor engagements. The Associate Director will also play a critical role in advancing the departments transition to data-driven issue identification and mitigation, leveraging technology and analytics to enhance operational efficiency. The role includes direct people management responsibilities and will contribute to the development and implementation of new systems and processes to support departmental and organizational needs. Global experience is preferred, as Eisai continues to expand its coordination of regional compliance teams. This job is hybrid, 3 days on site in Nutley, NJ (Tuesday Wednesday and Thursday).

Key Responsibilities

  • Lead the development and execution of the annual Ethics & Compliance monitoring plan, including :
  • Live monitoring of speaker programs and commercial ride-alongs
  • Transactional reviews of commercial call logs and HCP payment records
  • Serve as the operational lead for Eisai U.S.s Compliance Monitoring Program, managing internal resources and external vendors
  • Communicate monitoring findings to senior business leaders and collaborate on remediation strategies
  • Support investigations by conducting data reviews to identify potential compliance risks or violations
  • Partner with Commercial Operations, IT, and Finance to understand existing systems and data sources, and optimize monitoring capabilities
  • Drive automation and process improvements using technology and AI to streamline monitoring workflows
  • Utilize compliance systems to support audits and investigations
  • Propose and project manage new system implementations, including vendor selection and onboarding
  • Present updates to senior leadership on compliance trends, regulatory changes, and program enhancements
  • Contribute to compliance RAMP (Risk Assessment and Mitigation Plan) projects and cross-functional initiatives
  • Deliver system training to business stakeholders and recommend improvements to existing training programs
  • Develop and mentor team members, ensuring cross-training and knowledge sharing
  • Support global compliance efforts by identifying opportunities for system efficiencies and harmonization
  • Manage at least one direct report

Qualifications

  • Bachelors degree in a related field, JD from an accredited law school or CPA preferred
  • Minimum 7 years of experience in healthcare compliance within the pharmaceutical or biotech industry
  • Experience in monitoring / auditing health care compliance-related systems in the pharmaceutical or biotech industry
  • Experience with data analytics tools such as Tableau or other reporting tools to create meaningful summaries of insights from multiple data sources
  • Vendor management and people management experience
  • Strong understanding of key healthcare laws and regulations, including :
  • PhRMA Code
  • Federal Food, Drug, and Cosmetic Act
  • Anti-Kickback Statute
  • False Claims Act
  • OIG / DOJ Guidance
  • Federal and State Transparency laws
  • Foreign Corrupt Practices Act
  • Proven project management skills with the ability to prioritize and manage multiple initiatives
  • Proficiency in Excel and PowerPoint; experience with Veeva, Concur, and CRM systems strongly preferred
  • Excellent communication skills with the ability to translate data into actionable insights
  • Strong interpersonal and collaboration skills across cross-functional teams
  • Demonstrated ability to develop innovative solutions to complex challenges
  • Willingness to travel up to 20%
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