Eisai
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re 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 world's most widely-used treatment for Alzheimer’s 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 Eisai’s U.S. Ethics & Compliance team, responsible for implementing the execution and evolution of Eisai’s 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 Eisai’s 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 department’s 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
Bachelor’s 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
Demonstrated vendor management and people managementexperience
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%
Skills:Business Acumen, Communication & Cross-functional Influence, Compliance Knowledge/ Expertise, Critical Thinking & Business Agility, Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management, Mentoring/ People Development, Stakeholder Management (Legal/ Compliance)Eisai Salary Transparency Language:
The base salary range for the Associate Director, Compliance Operations is from :167,600-220,000Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://us.eisai.com/careers-at-eisai/benefits.
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
The Associate Director, Compliance Operations will be a key member of Eisai’s U.S. Ethics & Compliance team, responsible for implementing the execution and evolution of Eisai’s 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 Eisai’s 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 department’s 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
Bachelor’s 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
Demonstrated vendor management and people managementexperience
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%
Skills:Business Acumen, Communication & Cross-functional Influence, Compliance Knowledge/ Expertise, Critical Thinking & Business Agility, Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management, Mentoring/ People Development, Stakeholder Management (Legal/ Compliance)Eisai Salary Transparency Language:
The base salary range for the Associate Director, Compliance Operations is from :167,600-220,000Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://us.eisai.com/careers-at-eisai/benefits.
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation