Newark Metro Area, NJ
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 Dailymed
Maintain, catalog, and retain all labeling materials in accordance with company policies, procedures, and technologies
Additional labeling / organizational responsibilities as needed
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 Sharepoint.
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