Labeling Specialist

LanceSoft Inc; Jersey City (NJ); On-site; USD 60,000 - 75,000; Full time

Job summary

A regulatory compliance organization is seeking a Labeling Specialist in Jersey City. This role involves preparing high-quality labeling documents for FDA submissions, proofreading, and managing labeling processes for brand prescription products. Candidates should have 2+ years of experience in pharmaceutical labeling and a solid understanding of FDA regulations. Proficiency in Microsoft Office and good communication skills are essential. This position offers a collaborative environment and opportunities for independent task management.

Qualifications

• 2+ years of pharmaceutical labeling experience.
• Familiarity with medical terminology.
• Basic understanding of FDA labeling regulations.

Responsibilities

• Assist labeling managers with overall labeling process.
• Proofread package insert and packaging components.
• Prepare red‑line documents and comparison charts.
• Complete electronic drug listing and convert label to SPL.
• Maintain and post correct labels on company websites.

Skills

Excellent written communication

Organizational skills

Ability to work independently

Cooperative teamwork

Flexibility in managing priorities

Education

BA/BS with a Scientific or Regulatory background

Tools

Microsoft Office

Excel

Word

Outlook

SharePoint

Job description

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.

Qualifications

• 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

Additional Information

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