Job Details

  • Title: Labeling Associate
  • Code: RCI-9844700
  • Location: Princeton New Jersey (NJ) 08540
  • Posted Date: 02/04/2020
  • Duration: 10 Months
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  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 company‚Äôs 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

Skills:

  • 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.

Education:

  • 5-8 Years Pharmaceutical Labeling Experience
  • SPL, Word, Excel, PowerPoint
  • Minimum BA degree