Eisai US · 6 hours ago
Compliance Business Partner – Associate Director
Eisai US is a growing pharmaceutical company focused on neurology and oncology, dedicated to satisfying unmet medical needs. They are seeking a Compliance Business Partner to support their healthcare compliance program, ensuring alignment with legal and ethical standards while embedding compliance into daily operations.
BiotechnologyHealth CarePharmaceutical
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
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
Qualification
Required
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
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
Experience with training development including the use different training modalities for training effectiveness and impact is desirable
Benefits
Eisai Inc. Annual Incentive Plan
Eisai Inc. Long Term Incentive Plan
Company employee benefit programs
Company
Eisai US
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. It is a sub-organization of Eisai.
H1B Sponsorship
Eisai US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (21)
2023 (12)
2022 (41)
2021 (14)
2020 (22)
Funding
Current Stage
Late StageRecent News
Company data provided by crunchbase