Labeling Associate Job

Company Name:
Labeling Associate
Labeling Associate needed for a contract opportunity with Yoh's client located in Princeton, NJ. The Big Picture - Top Skills You Should Possess: - Labeling - FDA Submissions - FDA Regulations What You'll Be Doing: - 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. What You Need to Bring to the Table: - Three (3 ) years of Pharmaceutical Labeling Experience. - SPL, Word, Excel, and PowerPoint. What are you waiting for? Apply Now! Recruiter: Kara Lloyd Yoh, a Day and Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. J2W: SCIENTIFIC; J2W: CLINICAL; J2W: PROF MONJOBJ2WNECLIN Ref: SFSF: LS MYK62683JR

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