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Labeling Associate
Ref No.: 18-18279
Location: Princeton, New Jersey
Job Description: Prepare, review, approve and manage labeling for pharmaceutical products for FDA submission in accordance with FDA regulations.

RESPONSIBILITIES
• Responsible for the creation of pharmaceutical labeling drafts for submission to FDA based on Reference Listed Drug labeling, FDA requirements and Sandoz requirements.
• Responsible for the creation of labeling in SPL and PLR format.
• Responsible for working with outside vendors for creation of labeling proofs and ensuring accuracy of final labeling.
• 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, USP updates and updates for new Regulatory requirements.
• 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.
EXPERIENCE
5-8 Years Pharmaceutical Labeling Experience
KNOWEDGE
SPL, Word, Excel, PowerPoint