Nancy B. Cundari

Experience

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  CEGEDIM

  Sept 1982 - Jul 2005

  Director of Compliance and Quality Assurance/Control

  • Provide support services and marketing solutions for the pharmaceutical industry including sampling, indigent care, vacant territory, and new product launches• Served on various management teams and executive committee• Prepared state and federal licensing for pharmacy and drug distributor• Facilitated FDA, DEA, and pharmaceutical audits• Responsible for DEA validation, security and ARCOS reporting• Developed internal standard operating procedures and manuals• Conducted DEA, current Good Manufacturing Practice (cGMPs) and Prescription Drug Marketing Act (PDMA) compliance and training• Implementation of quality assurance and quality control initiatives• Managed Patient Compliance Programs• Utilized DEA, AMA, and mid-level practitioner databases• Special assignment included a six month project management initiative planning and setting up a secondary repackaging facility for injectables and vaccines. Show less

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  Heritage Golf Club

  Oct 2005 - Sept 2011

  Controller

  • Controller of Golf Resort complex that owns and operates 7 golf courses, banquet facilities, and tennis center on Hilton Head Island• Responsibilities included overseeing daily cash deposits, accounts receivable, accounts payable and generation of monthly member statements; preparing monthly journal entries and financial statements; facilitating annual budgets; performing account reconciliations, account analysis, and auditing functions; and implementing inventory controls and quality control initiatives• Conversion and integration of new accounting software Show less

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  Akesis, LLC

  Jan 2012 - Jul 2015

  Finance Administrator

  • Finance Administrator and business analyst for Akesis, a contract research organization conducting phase 2 and 3 clinical trials and regulatory consulting services for the pharmaceutical, biotech, generic, formulation, and device industry• Liaison for workmen comp audits, health insurance provider, 401K administrator, and outside accounting firm• Gathered independent contractor paperwork including W-9 forms for 1099 reporting• Involved with budgeting, ad hoc reports, and special projects as needed• Contract management pertaining to sponsors, sites, and other parties including master service agreements, start up agreements, work orders, consulting agreements, and confidentiality agreements. Monitoring of vendors and sites to ensure compliance with contracts, tracking of actual expenses against budget amounts in contract, ensuring timelines/milestones were met, and tracking of patient enrollments through data management reports• Proficient computer skills with Microsoft Office Suite and Microsoft 365 including Excel, Word, Power Point, Outlook, SharePoint, Lync/Skype, QuickBooks, and extensive Internet research experience Show less

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  Cundari & Cundari, Certified Public Accountants

  Aug 2015 - now

  CPA