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Tracy has 20 years of experience in the health sciences industry. She specializes in assisting pharmaceutical manufacturers and biotechnology companies with identifying and mitigating regulatory compliance risks. Tracy also provides other types of consulting services to academic medical centers hospitals and long-term care organizations. She regularly works with clients' in-house legal counsel compliance officers senior operations professionals and outside legal counsel.
Professional Experience
Tracy has over 10 years of consulting experience. Prior to joining Huron she was an Associate Director at Navigant Consulting Inc. in the Pharmaceutical practice. Prior to Navigant she was with Ernst & Young LLP for 10 years most recently in their Health Sciences Investigative and Disputes Services practice.
Representative examples of Tracy's engagement experience include:
Regulatory/Billing Compliance/Clinical Trials
Assisted a pharmaceutical company's Corporate Compliance office with an assessment of existing compliance audit capabilities in order to determine an effective organizational structure for its new Corporate Compliance Audit function.
Assisted a biotechnology company with a franchise compliance assessment of a product which included review of Medical Affairs Sales & Marketing and Commercial Contracting activities.
Assisted a major Academic Medical Center with a clinical trials billing audit.
Assisted a pharmaceutical company with a compliance assessment of its Phase I through III clinical trial activities.
Assisted a pharmaceutical company with a compliance review of its post-marketing clinical trial activities.
Sales and Marketing
Conducted several compliance risk assessments of sales and marketing activities for various pharmaceutical companies including review of policies procedures and training manuals and analysis of transactional data related to payments to health care professionals.
Conducted review of sales force sales call notes for potential violations with the PhRMA Code on Interactions with Healthcare Professionals.
Conducted a compliance review of a pharmaceutical manufacturer's sales force time and expense reports.
Corporate Compliance
Assisted a pharmaceutical manufacturer with an assessment of its Corporate Compliance Program; revised the Code of Conduct and developed policies and Standard Operating Procedures.
Independent Review Organization (IRO)
Led multi-year IRO engagements for several healthcare provider companies.
Education & Certifications
Master of Business Administration Union College - Graduate Management Institute Schenectady NY
Bachelor of Science Biology Trinity College Hartford CT
Six Sigma Green Belt Certification
Clinical Research Monitor training
Professional Associations
American Health Lawyers Association
Association of Clinical Research Professionals
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