Job Summary

This position assists the U.S. Ethics & Compliance (E&C) Governance, Risk Management, and Compliance (GRC) function supporting the Chief Compliance Officer in executing an effective compliance program. The Manager, Healthcare Law Auditing & Monitoring, executes the annual plan by conducting quarterly monitoring and may perform audits and complete other assessments of promotional and non-promotional activities.

Job Description

• Lead quarterly monitoring of data related, but not limited to emails, expenses, call notes, speaker programs, and HCP spend to help to ensure compliance with healthcare laws, regulations and guidance (such as the Anti-Kickback Statute, False Claims Act, OIG Guidance for Pharmaceutical Manufacturers, PhRMA Code, FDCA and PDMA).
• Execute monitoring or audits of processes and/or functions related to promotional and non-promotional activities, including, but not limited to, promotional materials, prescription drug samples, clinical trials, publications, and pricing agreements. Perform steps in the audit process including interviewing stakeholders, testing controls, communicating findings to stakeholders, drafting reports, and tracking corrective actions.
• Assist with conducting the annual U.S. Compliance Risk Assessment, including conducting interviews and drafting reports.
• Analyze and monitor compliance data and metrics to identify trends and assess the effectiveness and efficiency of monitoring activities and implement corrective actions, as needed. Contribute to continuous improvement of the U.S. E&C Compliance analytics platform.
• Prepare reports that summarize areas of non-compliance and risks identified through monitoring activities.
• Engage cross-functionally with other U.S. E&C teams and internal stakeholders and collaborate with them on compliance matters.
• Perform live monitoring (as needed) with domestic travel up to 25%.
• Possess and maintain an up-to-date knowledge and understanding of federal and state laws and regulations, industry codes of conduct and developments, and best practices applicable to the company's policies, practices or operations, including but not limited to the Sunshine Act, the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, PDMA, AMA, and industry guidance documents, regulations regarding the promotion of marketed products, clinical trial regulations, and the False Claims Act and anti-kickback statutes.
• Support Associate Director, Healthcare Law Auditing & Monitoring with other assignments as needed.

Qualifications/ Required

Knowledge/ Experience and Skills:

• Lead by proactively taking ownership of tasks and projects and effectively communicating results to internal partners on compliance matters.
• Strong organizational skills and the ability to effectively execute responsibilities independently with minimal oversight.
• Able to work independently as an individual contributor and in a team setting.
• Experience with data analysis, including ability to work with large amounts of data and organize results in a meaningful way to identify trends and potential red flags.
• Strong verbal and written communications skills to communicate effectively with individuals up, down, and across the organization.
• Strong interpersonal and project management skills.
• Analytical thinker with strong conceptual and problem-solving skills.
• Quick learner with the ability to analyze and identify new and emerging risks.
• Bachelor's degree in a related field.
• 6+ years monitoring or auditing experience.

Educational Qualifications

• Pharmaceutical, healthcare, or related industry experience
• Understanding of healthcare laws and regulations and sales and marketing activities
• CIA, CPA, or other certification in accounting, compliance, or auditing

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.