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Work Background
McKessonSr. Mgr, Compliance, CoverMyMeds by McKesson
Nov. 2020 - Aug. 2024Served as privacy & compliance lead for Sales, AKS, FCA, HIPAA, TCPA, CAN-SPAM, FTC, Marketing, Conflicts of Interest and various state and federal privacy laws. • Partnered with business leaders and cross-functional teams to ensure regulatory compliance, providing timely, practical guidance on complex issues to help navigate challenges while maintaining operational efficiency and minimizing risk.
• Advised business regarding data sharing between business units based on consent language and required disclosures working to revise approach to ensure ability to connect patient data along patient journey.
• Led reporting and investigations, using AI analytics to improve issue detection, root cause analysis, and reporting efficiency. Developed strategies and provided trained on compliance best practices.
• Reviewed data breaches, providing root cause analysis and follow-up reporting, utilizing AI-powered systems for real-time anomaly detection.
• Developed and delivered compliance oversight, training, and communication programs for regulations including AKS, FCA, HIPAA, FCPA, GDPR, and Sunshine Law.
• Revised and implemented compliance and privacy policies, leading a team of four to train employees and field sales teams.
Insys Therapeutics, Inc.Interim Chief Ethics Officer, Director of Compliance
Mar. 2019 - Jul. 2019Chandler, AZAssumed the role of Chief Compliance Officer during critical negotiations of the CIA, leading a team of three compliance professionals to effectively implement CIA requirements and successfully guided the organization through the closure of the business
• Led compliance efforts during OIG negotiations on a Corporate Integrity Agreement, overseeing Antikickback Statute, False Claims Act, Sunshine Law, and TIRF REMS compliance; developed and delivered training to ensure business alignment with CIA requirements.
• Managed a team of three compliance professionals, overseeing audits, monitoring, and team development.
• Launched a monthly compliance newsletter for sales and marketing, using gamification to engage employees on current compliance issues.
• Led investigations into potential violations, collaborating with cross-functional teams to determine root causes and corrective actions.
• Revised the Suspicious Order Monitoring process for opioid products to prevent diversion.
• Presented compliance updates to executive management and the Board, highlighting risks and improvement opportunities.
CR BardAssistant General Counsel - Compliance
Mar. 2016 - Oct. 2018Tempe, AZProvided comprehensive compliance oversight, training, and guidance for two divisions of leading medical device company, focusing on regulatory compliance with AKS, FCA, FCPA, HIPAA, GDPR, and Sunshine Law.
• Revised and implemented compliance and privacy policies and conducted comprehensive training sessions for all employees and field sales teams in groups of 20 to 500.
• Implemented monthly compliance newsletter across sales and marketing organization tied to current issues being detected, using gamifying techniques to drive engagement.
• Led investigations into potential compliance and privacy violations, working in tandem with business functional heads and HR to identify root causes and implement corrective actions.
• Managed team of four compliance professionals, overseeing auditing and monitoring activities, and guiding teams professional development in company.
• Offered legal analysis and guidance on the application of healthcare laws and regulations to various business practices, including customer contracting, clinical trial agreements, rebates, marketing surveys, and advisory councils.
• Managed Federal and State Sunshine reporting obligations, ensuring accurate and timely reporting and addressing any discrepancies or disputes as needed. • Conducted quarterly meetings with the compliance committee and management team to review the state of the compliance program and identify areas of potential risk.
• Ensured compliance of marketing materials with regulations enforced by the FTC, FDA, and other relevant authorities governing advertising in the medical industry.
DiaceuticsChief Operating Officer
Jan. 2010 - Jan. 2013Diaceutics is the leading provider of personalized medicine consulting, software (SaaS) and service solutions for the pharmaceutical and diagnostic industries.
• Responsible for implementation of day-to-day operations of growing virtual consulting and software company spread across multiple continents, identifying mechanisms to improve communication and workflow across organization as well as identifying and mitigating areas of risk in internal structures.
• Oversee development, progress and implementation of corporate strategy and five year comprehensive plan, setting appropriate timelines and goals, as well as execution of new divisions and product plans. • Continue to manage overall business development opportunities, ensuring integration of new business units into existing opportunities, including network development.
• Developed corporate marketing and communication strategy and supporting materials (including PPT presentations, fact sheets, videos, webinars, white papers and peer reviewed publications) to ensure industry position as a thought leader and more consistent engagement with existing contact base.
Sandra Day O'Connor College of Law, Arizona State UniversityVisiting Faculty Fellow, Center for Law, Science and Innovation
Jan. 2008 - Jan. 2010Visiting Faculty Fellow in the Center for the Study of Law, Science, & Innovation focused on the intersection of law and personalized medicine, taught Genetics & Law and Bioethics & Law. I continue to lecture on the microbiome and precision medicine.
DiaceuticsCorporate Counsel, VP Business Development
Jan. 2007 - Jan. 2010• Responsible for developing and fostering personalized medicine specific network to increase company visibility, develop new clients and create opportunities for cross-industry collaboration.
• Identify potential new prospects and create strategies to engage and build contacts to cultivate long-term client relationships.
• Identified and closed $1.5 million in business development opportunities annually, including deals with five major pharmaceutical companies and three key diagnostic companies.
• Identified internal products and services capable of being packaged and monetized to diversify company offerings to ensure more consistent corporate income stream.
• Independently created annual, invitation-only multi-disciplinary summit between key personalized medicine leaders (including representatives from the pharmaceutical and diagnostic industries as well as the regulatory agencies and payer community) to discuss issues impeding progress in the space.
• Secured numerous speaking engagements at industry conferences under a strict corporate policy of not sponsoring events; wrote and co-authored numerous articles accepted for publication in both peer review and other industry journals.
• Represent the company in speaking engagements at conferences, client sponsored events, industry meetings and with key clients.
Nixon PeabodyAttorney
Jan. 2006 - Jan. 2007Created specialization in pharmacogenomics speaking to members of the pharmaceutical and venture capital industries on risk management issues relating to potential litigation liabilities in the personalized medicine space.
Kaye Scholer LLPAttorney
Jan. 1996 - Jan. 2002Complex pharmaceutical litigation experience in state and federal courts, including federal MDL actions, with expertise in patent, trademark and product liability matters. Managed nationwide products liability litigation concerning the prescription drug Rezulin, including: • Directed and supervised in-house legal team of 40+ attorneys and staff;
• Coordinated daily litigation activities and reviewed work product of nationwide local counsel in 48 states;
• Advised local counsel on litigation strategy and coordinated actions across jurisdictions; budget oversight for in-house and local counsel;
• Developed and implemented databases to capture and track information both for litigation and client insurance reporting requirements;
• Analyzed cases for mediation/settlement purposes; prepared for and represented client at mediations.
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