Labeling Specialist

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 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 red-line 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
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.

•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.
•Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, and SharePoint

All your information will be kept confidential according to EEO guidelines.