Michelle Lomonte
Executive Director, Compliance & Integrity @Boehringer Ingelheim
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WORK HISTORY
Executive Director, Compliance & Integrity @Boehringer Ingelheim
Ridgefield, CT, US
Lead 7 direct reports to support business stakeholders within Medicine and Regulatory Affairs and the Innovation Unit (R&D) Divisions. Deliver compliance advice/tools/ guidance to business partners and assist in development of therapeutic areas and functional strategic and tactical plans. Assess compliance risk for medical and R&D efforts. Lead compliance investigations across all USA business unit operations. Report to Chief Compliance Officer.EXECUTIVE ENGAGEMENT: Establish(ed) trusted relationships with unit SVPs and other Medicine & Innovation Unit senior leaders. Conduct one-on-one meetings with business unit leaders. Deliver compliance support on strategy, tactics, and operations.USA COUNTRY MANAGING COMMITTEE / BOARD OF DIRECTORS: Present with Compliance Leadership Team on investigation metrics, strategic projects, auditing and monitoring plans and metrics, and provide updates on the compliance landscape to senior executives and Board.HUMAN PHARMA REVIEW COMMITTEE GOVERNANCE COUNCIL: Represent Compliance on steering committee to oversee operational requirements for review/approval of promotional, scientific, company, payor guidance, and disease state education communications.USA CORPORATE EXTERNAL FUNDING ALIGNMENT: Led team to assess external program funding (grants, charitable contributions, other) across Human Pharma. Standardized and consolidated business practices.HELPLINE AND INVESTIGATION CASE MANAGEMENT SYSTEM: Led team to author RFP, select and implement new helpline system, update processes and data analytics and roll-out training. MEDICINE DIVISION FULL-TERM CIA LEADERSHIP: Reviewed Medicine procedures and ensured appropriate compliance controls (HCP engagements, publications, medical information, medical funding, field-based medicine, clinical trial recruitment, and more). Successfully navigated full-term of CIA within Medicine Division.COMPLIANCE TRAINING: Create/deliver specialized compliance training across all areas.
EDUCATION
Seton Hall University School of Law
Juris Doctorate
The College of New Jersey
BA, Political Science
SKILLS
ABOUT MICHELLE LOMONTE
Pharmaceutical Attorney and Healthcare Compliance Officer with deep and broad experience in drug development, lifecycle management, life sciences, compliance, compliance investigations, policy and procedure development, business partnering, business development, and complex commercial transactions. Extensive knowledge of the pharmaceutical industry and relevant laws, such as Anti-Kickback statute, Food and Drug Law, Open Payments Act, False Claims Act, Foreign Corrupt Practices Act, and PhRMA Code.Successes at Boehringer Ingelheim and Eisai include: BUSINESS PARTNER, MEDICINE LEADERSHIP TEAM (BI): Represent Compliance on 25-member Medicine Leadership Team. Deliver presentations and update members on compliance changes. Act as business partner to shape business and regulatory strategies. LEADERSHIP / CULTURE OF COMPLIANCE BUSINESS PARTNERSHIP (BI): Lead Compliance program efforts in Medicine and Regulatory Affairs and the Innovation Unit (R&D) Divisions. Hired and trained team to grow from 3 to 7 dedicated members. Successfully cultivate(d) customer-centric team culture. Achieved retention rate above 90% over 10 years. USA CORPORATE EXTERNAL FUNDING ALIGNMENT (BI): Drove cross-functional team to assess external program funding (grants, charitable contributions, other) across Human Pharma. Restructured business practices to increase flexibility and address emergent business needs while ensuring compliance with the external enforcement environment. COMPLIANCE INVESTIGATION LEADERSHIP & OVERHAUL (BI): Oversee Compliance Investigation team for all U.S. business entities. Centralized nationwide functions and hired new team members to create first USA-wide investigation protocol. Reduced time to close workplace investigations by 50%. Nominated by Global Chief Compliance Officer to lead international training program on investigatory best practices. CONTRACTING OPERATIONS FUNCTION LAUNCH / PLAYBOOK (Eisai): Took over ad hoc contracting processes and established Contracting Operations Function. Updated existing contract templates and drafted company-first Contracting Playbook. Significantly reduced average time to negotiate/approve contracts. Recognition- BI “President Award” for improving Medical and Commercial interface, 2016 - BI “President Award” for creating new field-based medicine role, 2016 - BI “President Award” for CIA implementation activities, 2016 - Eisai “Above and Beyond Award” for development of Legal Contracting function, 2011
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