Manager, Healthcare Auditing & Monitoring

Job Summary 

This position assists U.S. E&C's 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 transactional analyses and live monitoring and may perform operational audits, and complete other auditing and monitoring assessments of promotional and non-promotional activities. This will be a hybrid role based in Princeton, NJ or Rockville, MD.

Job Description 

• Lead quarterly transactional analyses 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 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 HLAM monitoring activities.    

• Lead other ad-hoc reviews, inquiries, and investigations as required. 

• Collaborate 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: <