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Scientific. Clinical. Software Engineering

Pharmaceutical Proofreader/Labeling Assistant

New Jersey All, NJ

Job Type: Clinical Job Number: JN -062020-26883 Region: New Jersey All

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:

BA/BS or relevant experience

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; XML experience is a plus

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