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INTRODUCTION

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.

ROLE AND RESPONSIBILITIES

Develops, implements, administers and certifies compliance policies, procedures, and practices. Ensures alignment with legal and ethical standards of the organization. Provides compliance advice, investigates complaints and verifies deficiencies are corrected. Develops employee communication and training programs that focus on the elements of a companywide compliance program. Enforces anti-bribery and anti-competition laws. Analyzes metrics and audits functional compliance program. Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program.

Compliance Business Partner – Associate Director

The Ethics and Compliance Department requires a dedicated Compliance Business Partner to support and strengthen Eisai’s healthcare compliance program and accelerate business decision-making. This role will embed compliance into daily operations by partnering with functional leaders, establishing effective policies and training, and ensuring robust oversight and assessment of activities/engagements involving HCPs/HCEs and other customer groups to ensure appropriate risk mitigation and controls are established. This business partner role will specifically support the Market Access team which includes Payer Markets, Patient Support Services, Trade, GPO and Specialty Markets and as well as other Eisai functions with the following business critical activities:

• Provide guidance and support to various Business functions, ensuring a channel to address questions, concerns, and receive prompt assistance related to policies, procedures, and compliance risks.
• Develop and deliver compliance training programs to educate on the regulatory environment and company specific compliance requirements.
• Complete Bonafide Service Fee assessments.
• Conduct compliance risk assessments and assist with compliance audits and investigations.
• Draft and implement compliance policies, procedures, forms, and tools to establish an effective compliance program and proactively address areas of risk.
• Conduct conflicts of interest assessments.
• Perform reviews of external funding requests and fee for service engagements.
• Monitor compliance metrics and assist with reporting to senior management and regulatory agencies.
• Partner with the Compliance Operations team to ensure monitoring program, and state/federal reporting requirements are consistently managed.
• Work cross-functionally with Commercial, Medical, Clinical/R&D, Regulatory and Legal partners and other Corporate Service functions as needed.

BASIC QUALIFICATIONS

- Bachelor’s/Master’s degree in related field or JD from an accredited law school with 7+ years’ experience in legal and/or in-house compliance, preferably in pharmaceutical/biotech industry.
- Excellent knowledge of key laws and regulations impacting the pharmaceutical industry including the PhRMA Code; Federal Food, Drug, Cosmetic Act; Anti-Kickback Status; False Claims Act, OIG/DOJ Guidance; Foreign Corrupt Practices Act; and federal and state transparency and disclosure laws.
- Experience in conducting compliance audits, risk assessments, or investigations.
- Experience with training development including the use different training modalities for training effectiveness and impact is desirable.
- Demonstrated experience with policy/procedure development and implementation.
- Proven performance in earlier role.
- Able to travel for business as needed (20% on average).
- Hybrid onsite 3 days per week in our Nutley, NJ office (Tuesday, Wednesday, Thursday).

PREFERRED QUALIFICATIONS

- 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).

COMPENSATION

- Salary Range: $168,700-$221,400.

Under 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 the company benefits page. 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.