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

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.

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.