Prepared and critically reviewed labeling files at all stages of the development life cycle (including submission, deficiency, launch and commercially available labeling) and understood unique requirements at each phase of the process. Formatted and edited label copy in accordance with FDA guidelines and design regulations with extreme accuracy and quality. Collaborated with CMOs (oversight of projects and conference calls) and internal stakeholders to create and update label copy and design for FDA submissions or to respond to deficiencies or RLD updates. Assessed labeling priorities, proofreading and updated FDA urgent requests.
