Job Details

  • Title: Pharmaceutical Proofreader/Labeling Assistant
  • Code: RCI-01067
  • Location: Bridgewater New Jersey (NJ) 08807
  • Posted Date: 05/29/2020
  • Duration: 6 Months
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  Job Description

• Perform the review and approval activities for U.S. packaging components in artwork repository
• Prepare and upload artwork changes into the artwork repository
• Proofread labeling documents in all phases of the submission process, including multiple-document cross reads and SPL, for grammar, format, spelling, to ensure labeling conforms to regulations and internal guidelines, and for accurate duplication of changes
• Preparing the summary of labeling portion of Annual Reports for drugs and biologics and upload to document repository
• Performs other regulatory labeling operations functions as needed

Requirements:
• 1-5 years experience in Pharmaceutical Regulatory Labeling Operations
• Understanding of the pharmaceutical industry, drug packaging development, and labeling maintenance processes and objectives
• Working knowledge of FDA regulations and guidances for labeling, AMA manual of style, proofreading experience, TVT, Veeva, Insight for Viewing, SPL, Adobe Acrobat Pro/DC, eCTD, Microsoft Office with advanced MS Word skills, knowledge of medical/pharmaceutical terminology.