Overview
Laura Skinner is a Managing Director in the Life Sciences Consulting Group in the Litigation Department of Paul Hastings’ New York office. Laura has 25 years of experience serving the global life sciences and healthcare industries. She is a strategic, detail-oriented finance and operations professional with acknowledged experience in leading sales and marketing compliance, financial management, operational consolidation, and process improvement engagements. She has a keen understanding of the challenges facing her clients’ organization across the product life cycle in operations, compliance and technology, leading diverse cross-functional teams in developing compliance and operational frameworks. She specializes in fair market value assessments, compliance program development, risk management, ongoing operations, and healthcare professional engagement for commercial and medical affairs services.
Ms. Skinner provides advisory services and is not a licensed attorney.
Education
- University of Pittsburgh, Master of Business Administration
- Virginia Tech, Bachelor of Science, Finance
- Certified Project Management Professional
- Women’s Leadership Program, Deloitte
Representations
- Led compliance assessments for life sciences companies, advising on effective compliance programs based on industry regulations and industry standard practice
- Led patient engagement assessments, operationalizing patient engagement procedures including fair market value frameworks and training based on industry regulations and practices
- Led the development and implementation of fair market value models and frameworks for fee-for-service activities and clinical studies in compliance with corporate and legal regulations, including setting company standards and training business partners on the policies and practices
- Assisted clients as part of the Independent Review Organization that performs Corporate Integrity Agreement reviews (e.g., systems and transactions reviews) for the Office of Inspector General
- Conducted compliance audits of data related to speaker programs, advisory boards, clinical trial payments, consulting arrangements, investigator-sponsored trials, medical information requests, etc.
- Led the creation and development of interactRx™, a technology-enabled solution for the healthcare professional engagement process
- Led the review and documentation of company practices around the selection of third party distributors and provided guidance on process improvements to help determine compliance with the Anti-Kickback Statute
- Conducted live monitoring of promotional speaker programs and field observations with sales representatives
- Led an accounting system implementation, including the design, development, implementation, operation, and transition of a best practices model for an investment accounting department of one of the largest pension funds in the world
- Provided project oversight for a portfolio of finance, accounting, corporate governance, and tax projects for a large healthcare company restatement due to Sarbanes-Oxley regulations
- Laura is a frequent speaker at industry conferences on topics such as global compliance program scalability and harmonization, healthcare professional engagement, and effective use of data analytics
Involvement
- Women’s iMatter Leader, Huron
- Helping Hands Community Service Chair, Huron
- Together We Can, Guatemala Mission
- Helps Ministries, Cambodia Mission