Responsible for the creation of pharmaceutical labeling drafts, final print labeling, track change documents, and side by side comparison documents for submission to FDA based on Reference Listed Drug labeling, FDA requirements and Company requirements.
Responsible for the creation of labeling in SPL and PLR format.
Responsible for managing and tracking the review process for labeling pieces to ensure timely submissions to FDA.
Responsible for identifying changes needed for FDA approved labeling including updates to Reference Listed Drug, FDA communications, USP updates and updates for new Regulatory requirements.
Responsible for creation of new labeling for new applications.
Responsible for maintenance of all labeling files in accordance with internal procedures
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to work under tight deadline pressure and handle multiple projects.
Must have ability to take and follow directions. Familiarity with FDA Labeling guidelines (21 CFR) required.
Must possess excellent communication and organizational skills, be a team player and have a meticulous eye for details
Must possess excellent proofreading skills
Knowledge of generic drug labeling regulations and guidances.
Must know Word, Excel and PowerPoint.
Documentum/Change Control Systems
Education: 5-8 Years Pharmaceutical Labeling Experience. Prior experience in graphic design, desktop publishing.