Elaina McEwan is a Senior Manager in the Life Sciences Consulting Group in the Litigation Department of Paul Hastings and is based in the firm’s New York office. Elaina has over 12 years of life sciences industry experience assisting companies in mitigating evolving risk areas and maintaining compliance with industry regulations. She supports corporate compliance, legal counsel, and senior operations professionals on matters related to compliance program effectiveness, compliance and enterprise risk assessments, patient services compliance, sales and marketing operations, and government investigations. In addition to her consulting experience, Elaina has held in-house roles in sales and compliance for two global pharmaceutical companies.
Elaina provides advisory services and is not a licensed attorney.
- Seton Hall School of Law, Healthcare Compliance Certification, 2010
- Georgetown University: Bachelor of Science, Human Science, 2008
- Supported a multi-year engagement with a global pharmaceutical company to develop a comprehensive, enterprise-wide patient services compliance program involving the design and implementation of new processes and controls for various patient services activities, including Independent Charity Patient Assistance Program (ICPAP) donations/interactions, a free-drug program, and a copay/savings card programs, as well as specialty pharmacy and hub programs.
- Led the redesign of a global pharmaceutical company’s external funding program to include enhanced review and approval procedures for higher-risk funding requests. Engagement involved the development of standardized risk-ranking procedures for funding requests and a streamlined review and approval process that ultimately led to a more effective and efficient external funding program. The scope included medical education grants, sponsorships, charitable contributions, collaborations, and fellowships.
- Led numerous compliance program assessments for various life sciences companies at varying phases of program maturity (i.e., pre-commercial, post-commercial); developed and delivered compliance program roadmaps outlining prioritized worksteps and responsibilities for compliance gaps and risks identified.
- Managed multiple Corporate Integrity Agreement (CIA) readiness and implementation efforts for both pharmaceutical and medical device manufacturers, including policy and procedure gap assessment/development, monitoring program design, contract management and needs assessment design, covered/ineligible persons screening, identification & training process design, and certifications process design; additionally, managed over 10 Independent Review Organization (IRO) engagements.
- Led multiple patient services vendor assessments to review adherence to company-specific controls and industry standards.
- Led multiple engagements to assist companies in compliance policy and procedure design, creation, and roll-out.
- Led various commercial compliance efforts working in-house for a global pharmaceutical manufacturer.
- Ms. McEwan frequently speaks at industry conferences on topics including patient services compliance, commercial compliance, external funding risk mitigation, and auditing and monitoring program effectiveness.