Gladys Martin Email & Phone Number

Tampa, Fla

Reviewed and approved Advertising and Promotional materials. Developed SOPs for Labeling and Advertising Reviews. Established an Advertising Review Committee as well as a eRoom for review and approval of documents. Reviewed labeling for new drugs. Initiated the application process for State licenses.

-Supervision of one (1) executive, two (2) exempt and two (2) non-exempt employees.-Review and approval of all pharmaceuticals product advertising, dietary supplements and select medical device solutions.-Involved in the due diligence activities of new products.-Reviewed and approved clinical trial protocols for dietary supplement products, and Regulatory.

-Key expert in pharmaceutical product labeling for the corporation.-Manage the labeling review, approval, and disposition process of all pharmaceutical products for domestic and international markets, including approval of clinical trial labeling.-Develop draft labeling for new generic and proprietary products.-Developed databases to track labeling and.

-Label Committee chairperson- Managed the labeling review, approval, and disposition process of all pharmaceutical products for domestic and international markets, including approval of clinical trial labeling.-Developed draft labeling for new generic and proprietary products.-Prepared and submitted Adverse Event Periodic Reports to FDA-Managed the Medical.

-Label Committee chairperson – Coordinate the revision, review and approval of all labeling, advertising and promotional materials for pharmaceuticals and medical devices.-Direct liaison with FDA's DDMAC and CDER on labeling compliance related matters.-Responsible for the preparation, submission and maintenance of NDC numbers, drug listings, and state.

-Label Committee chairperson – Coordinate the revision, review and approval of all labeling, advertising and promotional materials for pharmaceuticals and medical devices.-Direct liaison with FDA's DDMAC and CDER on labeling compliance related matters.-Responsible for the preparation, submission and maintenance of NDC numbers, drug listings, and state.

Scientist in Materials Reserach and Process Development with responsibility in the management of the Characterization and Analytical laboratory. Developed biocompatibility testing methods, analytical and physical testing, Quality Control Procedures, SPC, GMP, inspection and measurement techniques. Managed several projects related to intravenous and.

Ba, Chemistry, Education

Hs Diploma