Labeling Assoicate

Responsibilities:

· Coordinate labeling projects to ensure regulatory compliance

· Provide guidance to team members on labeling regulations and process requirements

· Carry out project deliverables such as initiating, reviewing and implementing label creation/updates with extreme attention to detail

· Provide regular updates regarding labeling projects to cross functional departments to facilitate coordination for project completion timelines

· Forge relationships with thought leaders in their respective departments to enhance understanding of process needs

· Participation in project management meetings as the Clinical Development Operations representative · Responsible for the creation of pharmaceutical labeling drafts/Final for submission to FDA based on Reference Listed Drug labeling, FDA requirements and Client requirements.

· Responsible for the creation of labeling in SPL ( X-forms) and PLR/PLLR format.

· Responsible for working with outside vendors for creation of labeling proofs and ensuring accuracy of final labeling.

· Responsible for managing and tracking the review process for labeling pieces to ensure timely submissions to FDA

· Responsible for identifying changes needed for FDA approved labeling including updates to Reference Listed Drug, USP updates and updates for new Regulatory requirements.

· Responsible for maintenance of all labeling files in accordance with internal procedures

Position Requirements

· Ability to function well under pressure and balance multiple projects

· Dedicated, detail-oriented focus in project initiation and review

· Skills in project management concepts and software

· Must have ability to take and follow directions. Familiarity with FDA Labeling guidelines (21 CFR) required.

· Must possess excellent communication and organizational skills, be a team player and flexible to work as per the priority

· Bachelor's degree or equivalent experience

· Proficiency with Microsoft Office programs, including but not limited to Word, Excel, PowerPoint and Outlook

· Knowledge of global medical device labeling requirements

· Experience with translation activities

Job Type: Full-time

Pay: $25.00 - $28.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Basking Ridge, NJ 07920: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)

Work Location: One location

Salary : $25 - $28