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Labeling Specialist
Ref No.: 19-10275
Location: Madison, New Jersey
Sunrise System Inc. is currently looking for Labeling Specialist in Madison, NJ with one of our top client.
 
Job Title: Labeling Specialist
Job Id: 19-10275
Location: Madison, NJ 07940
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
Description
  • Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA).
  • Labeling documents include those prepared for FDA submissions, Annual Reports and PSURs in compliance with regulatory requirements and within company timelines.
  • Candidate will be required to work with limited oversight and have a basic understanding of FDA labeling regulations and FDA guidance's to the level of applying them effectively to all work output.
Specific responsibilities include
  • Assisting labeling managers with overall labeling process of brand prescription products
  • Proofreading of package insert as well as packaging components.
  • Preparing redline documents and comparison charts
  • Understanding of working in a digital workflow system and using online proofreading tools
  • NDC number assignment
  • Completion of electronic drug listing and conversion of label to structured product labeling (SPL)
  • Maintenance and posting of correct labels to company websites and Daily med
  • Maintain, catalog, and retain all labeling materials in accordance with company policies, procedures, and technologies
  • Additional labeling / organizational responsibilities as needed
Qualifications
  • Education Required: BA/BS
  • Education Preferred: BA/BS with a Scientific or Regulatory background 
Experience Preferred
  • 2+ years of pharmaceutical labeling experience; scientific background or familiarity with medical terminology.
  • Artwork and SPL experience is required.
  • Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, and Share Point.
Job-specific Competencies
  • Excellent written communication and organizational skills
  • Works cooperatively with others; can also manage tasks and priorities independently as needed.
  • Takes responsibility for his/her own performance; promptly notifies his/her manager about any problems that affect his/her ability to accomplish planned goals
  • Demonstrates flexibility in managing changing priorities and demands
Knowledge of
  • Food and Drug Administration (FDA) regulations and guidelines.
  • Current FDA/Regulatory Affairs submission requirements.
  • Logistics and work of the pharmaceutical industry.
  • Current Company policies, practices and procedures, including safety rules and regulations. 
Contact
Rahul
Direct: (732) 272 0347| Email: Rahul.R@sunrisesys.com
Or
Michael Peng
Direct: (732) 272 0265 | Michael@sunrisesys.com