Hikma Pharmaceuticals USA Inc.

  • SR Labeling Associate

    Job Location US-NJ-Cherry Hill
    Posted Date 2 weeks ago(10/30/2018 5:49 PM)
    Job ID
    2018-4894
    Job Function
    Regulatory Affairs
  • Overview

    Position is responsible for overseeing the development and coordination of labeling and its implementation for the Cherry Hill site.

    Responsibilities

    1. Drafts all labeling for new ANDA products based on innovator’s labeling using West-Ward established format for Description and How Supplied sections.
    2. Drafts all revised labeling for marketed products based on FDA requirements and/or West-Ward proposed changes.
    3. Prepares responses to FDA on all matters related to labeling.
    4. Monitors labeling development from draft to final proof stage to assure compliance with FDA required schedules.
    5. Notifies and monitors Production Services of implementation dates for new or revised labeling.
    6. Prepares computerized listing of all approved current labeling and issues periodically.
    7. Prepares and/or monitors preparation of camera-ready artwork for graphic arts department and outside vendors.
    8. Attends team meetings on labeling/packaging issues.

    Qualifications

    BA/BS degree in relevant field with a minimum of 3 years experience in RA. Previous training and experience in proofreading as well as label coordination and development are required. Regulatory Affairs experience (FDA, USP, CFR) is a plus.

     

    Ability to work independently. Flexible and accommodating as priorities rapidly change. Ability to handle multiple priorities with short timelines. Extremely strong accuracy and attention to detail. Strong capabilities in various computer applications. Professional level oral and written communication skills. 

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