Wendy Wilcox Voice Talent

Presently a Senior Technical Editor with strong GMP, Quality, and Regulatory knowledge, supporting Labeling and Graphics Operations, global commercial manufacturing, and responsible for reviewing labels, proofs, and specification updates; compare labeling and graphics designers’ work to Regulatory source documents to ensure accurate and compliant labeling. -Contributes to the completion of all technical and operational activities for assigned labeling projects through collaboration with internal and external resources. -Manages the most complex processes across functions and interacts effectively with the other team members to ensure product labeling meets all requirements. -Responsible for reviewing and proofreading commercial labeling intended for domestic and multiple international markets, including multiple languages. -Responsible for ensuring the implementation of the correct and consistent transfer and implementation of approved regulatory text, graphs, charts, tables, etc. in a clear, accurate, and error free manner. -Ensures that packaging label copy and graphics are in accordance with regulatory, industry, and corporate style guidelines. -Update SOPs and documentation systems. -Recommends improvements and develops systems/policies to enhance labeling operations. Knowledge: Agile electronic documentation system and associated workflows. Proficient knowledge of current Good Manufacturing Practices (cGMPs). Strong verbal, technical writing and interpersonal skills. Proficient in Microsoft Office applications. Possesses a strong knowledge of the FDA and other Health Authority standards as well as regulatory guidance documents