Job Summary
The Labeling Associate reports to Labeling Manager of Regulatory Affairs and is responsible for the creation of labeling for inclusion in regulatory submissions and for post-approval maintenance of such labeling submissions. Interacts with project teams and regulatory agencies in relation to submissions and other relevant topics. Assists other labeling associates with tasks as needed.
This is a hybrid position, and the selected candidate will be required to work onsite in the Lake Zurich, Illinois office 3 days a week.
Salary Range: $65,000 - $85,000 per year
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most.
Responsibilities
- Accurately proofreading preprinted labeling material (vial/tray labels/cartons/package inserts, etc.).
- Creation of draft labeling for new products using innovator labeling, input from Medical Affairs and Vigilance, Product Development, Package Engineering, and/or Marketing; making changes where appropriate.
- Creating labeling in Structured Product Labeling (SPL for XML) format using specialized software for FDA submissions.
- Routine updates/revisions of product labeling utilizing innovator or leading competitor labeling or FDA deficiency letters.
- Interacting with contract manufacture customers on issues relating to labeling; builds and maintains professional and effective rapport with clients resulting in enhanced business relationships.
- Providing labeling documentation [draft or final printed labeling (FPL)] in response to deficiency letters within specified time frames based on corporate priorities; responsible for accurate interpretation of deficiency letters, providing accurate, approvable labeling for FDA submissions.
- Coordinating proofreading of labeling artwork; performing review of draft and final labeling for compliance with USP and FDA requirements. Responsible for maintaining an error-free environment with respect to all labeling components and documentation.
- Timely implementation of FDA approval letters and the determination of timely destruction of obsolete labeling in accordance with FDA requirements. Provides current approved artwork and electronic files to printing vendors upon request from manufacturing plants.
- Monitoring FDA websites for changes in innovator labeling and labeling regulations.
- Reviewing proposed USP labeling revisions to ensure timely implementation for Fresenius Kabi products.
- Maintaining labeling files for current / historical components and updates databases for current components, DCR’s, deficiency letters, etc.; maintains current label sample files.
- Providing labeling support for all active applications for annual reporting regulatory requirements.
- Additional tasks and duties as assigned.
Requirements
- Bachelor degree in life science/medical discipline or equivalent years of experience in field.
- At least three (3) years’ experience in the pharmaceutical industry or equivalent.
- Well-developed communication skills.
- Project Management experience
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
