Wendy Revenaugh Email and Phone Number

Responsible for providing overall global coordination of the entire clinical supplies lifecycle for the projects assignedResponsible for managing primary and/or secondary packaging and labeling design, drug projections, drug distribution and returns, drug inventory management, budgeting and developing project specific material for multiple projects at the same time Provides consultation services to clients regarding global packaging, labeling, and distribution requirements Serves as the main point of contact between the client, clinical project teams, third party vendors, and study sites Mentor New GCS PM and APMs on study activities associated with clinical supplies processes to ensure applicable timelines and metrics are met, including all regulatory, legal and financial aspects in accordance with Global SOPs and WPDs.

Project Management for Packaging and labeling of Clinical Trial Materials. Moved to Distribution Coordinator -managed distribution for multiple sponsors and trials.

Import/Export Shared Services. Specialized in harmonized tariff classification of pharmaceutical material, including API's finished products and manufacturing, laboratory equipment.

Coordinate logistics, regulatory and corporate requirements for US Customs clearance and deliveryManage databases with current US Customs classification information and FDA Importing requirementsGenerate reports interpreting Import Entry Auditing findings and trendsInvestigate, research and assign tariff classifications and FDA codes imported and exported biological material, drug substances, clinical supplies, R & D, manufacturing equipment and packaging components Apply knowledge of HTSUS and Customs Rulings Database to investigate and uncover duty savings opportunitiesAudit import entries for compliance with US Customs and Border Protection regulations

Pharmaceutical Drug Marketing Act (PDMA) Sample Compliance Auditor

Conducted on site PDMA random, annual and close-out inventory audits for pharmaceutical companies. Assisted sales reps in trouble-shooting inventory variances.Consistently completed and submitted error free documentation ahead of scheduled deadlines.