Denise R. Hess Email & Phone Number

Greater New York City Area

• Received emails or calls regarding client, subcontractor or field concerns. • Opened & classified Case, information obtained through an investigation from anyone or a company implicated in the initial complaint or compliment received.• Provided weekly reports of open and closed cases to internal and client account management for weekly directors meeting. • Developed plan of action to achieve customer satisfaction. • Monitored scheduled shifts from IVR reports to ensure client received contracted time for payable hours worked. • Entered into CRM system contract billing changes, Subcontractor changes, credits, deductions and extra billings• Communicated account requirements to new subcontractors.

Jersey City, New Jersey

• Responsible for all activities, regulatory related, to insure the compliance of all labeling to the federal, state, local and other applicable laws or guidelines. • Direct all activities relative to implementation of labeling across sites. • Keep up to date with OIG (Office of Inspector General) and DOJ (Dept. Justice) notices. • Provide input from above to responsible individuals for the purpose of compliance. • Interact with project teams in the development, compilation, proofreading and submission of all new and revised draft text labeling. • Maintain file system for previous and currently approved labeling for all products. • Maintain a chronological tracking sheet on the labeling of all products which is accessible to all Regulatory personnel.• Interact with QA personnel at various manufacturing sites, the Marketing Department and contract manufacturers in the review and sign-off of labeling.

Greater New York City Area

• Major projects included the developing and/or revision of labeling for drug and device products for domestic and/or international markets. • Enforced corporate, FDA, and industry standards into labeling. • Created tracking document utilizing Excel. • Developed and trained personnel in a quality system for the implementation of new/revised labeling for drug and device products. • Developed and maintain a system of creating/revising artwork in-house, to control and expedite changes in an expedient manner. • Developed a food kit to be use prior to a gastro-procedure. • Reorganized and made the existing label file system. • Took into consideration requirements of production labeling in the company Global format and compliant to the EU Directives to the guidelines of; internal domestic and international Regulatory Affairs, Marketing, Quality Systems, R&D, and Inventory Control. • Attended a Pharmaceutical Labeling conference(s) sponsored Barnett International Conference Group, RAPS Global Awareness: European Medical device Regulation, RAPS Drug & Medical Device Advertising and Promotional conference.