Senior Manager, Healthcare Law Auditing & Monitoring

Job Summary

This position assists E&C's Healthcare Law Auditing and Monitoring function supporting the Chief Compliance Officer in executing an effective compliance program. The Senior Manager, Healthcare Law Auditing & Monitoring, executes the annual auditing and monitoring plan by performing quarterly transactional reviews, leading operational reviews, and completing other auditing and monitoring assessments of promotional and non-promotional activities. The successful candidate will have an extensive audit experience with strong verbal and written communication skills.

 

Job Description

  • Lead quarterly transactional compliance reviews of data related to emails, expenses, call notes, speaker programs, meals, etc. as required by the Senior Director, Healthcare Law Auditing & Monitoring.
  • Lead and assist with periodic audits and other reviews of activities related to promotional functions, product related functions and payer related functions including but not limited to processes for: promotional materials, prescription drug samples, clinical trials, publications, pricing agreements, etc.  
  • Perform critical steps in the audit process including drafting announcement letters, conducting surveys, interviewing stakeholders, reviewing internal controls, executing sampling methodology, reviewing supporting documentation, preparing schedules of analysis, communicating findings to Audit Manager and stakeholders, drafting reports, and tracking corrective actions.
  • Assist with preparing reports for Executive Management and Committee meetings that summarize areas of non-compliance and risks as determined from HLAM activities.  
  • Collaborate with internal partners on compliance matters.  
  • Support Associate Director, Healthcare Law Auditing & Monitoring, with other assignments as required.
  • Lead other ad-hoc reviews, inquiries, investigations, and questions as required by Senior Director, Healthcare Law Auditing & Monitoring or other compliance partners.
  • Assist with annual planning of Healthcare Law Auditing and Monitoring program.
  • 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 2003 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.

 

Qualifications

Required

  • 8+ years internal audit or compliance audit experience
  • Proficient with auditing standards, concepts, and procedures.
  • Team oriented, effectively interact with peers, management, and other internal customers
  • Good understanding, comprehension, and ability to articulate auditing concepts
  • Efficient time management and organizational skills with the ability to multi-task
  • Ability to lead audit reviews and document results in audit reports
  • Strong level of comfort with data analytics and Microsoft Office Suite.
  • Able 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.  
  • Good organizational, interpersonal and project management skills.
  • Analytical thinker with strong conceptual and problem-solving skills.
  • Quick learner with the ability to analyze new and emerging risks.
  • Bachelor's degree in a related field.
  • Good working in a team atmosphere and as an individual contributor when necessary.

Preferred

  • Professional certification of CPA, CIA, or other certification in compliance, or auditing.
  • Strong knowledge of the healthcare/pharma industry
  • Knowledge of sales and marketing processes

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