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Label Editor/Proofreader (Pharmaceutical Industry)

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Our client is looking to hire a highly detail-oriented Label Editor/Proofreader. This is a fantastic career opportunity to work for a major, global pharmaceutical company. Qualified candidates include proofreaders/editors with solid project coordination skills working in a highly regulated industry. Please apply online or email ellens@aquent.com your resume, salary expectations and brief paragraph why you are the right candidate for this position.

JOB DESCRIPTION
Label Editor is accountable for the development, editing, approval, and control of pharmaceutical labeling manufactured in US/Puerto Rico regional plants and third party manufacturers. The position is also responsible for the creation and maintenance of labeling related specifications. The applicant must have the ability to assess the impact of a label change on other product labeling and manufacturing operations and assure compliance with FDA regulations and cGMP’s.

Major Responsibilities:

1. Manage and maintain labeling for assigned product lines. Initiate, prepare, review, approve and implement new or revised labeling. Assure label content meets corporate, Regulatory and FDA requirements.

2. Have the ability to interpret governmental regulations and have a basic understanding of the requirements for pharmaceutical labeling.

3. Evaluate the impact of a labeling change on associated labeling and manufacturing operations.

4. Create label copy for new drug applications (NDA’s) and ensure product filings have complete and accurate label content. Upon FDA approval, manage the flawless execution of approved labeling to meet operational goals.

5. Review proposed changes to regulations, USP/NF or FDA Guidelines, and determine impact to labeling. Initiate and manage changes to assure compliance.

6. Explore and implement continuous improvement opportunities that increase efficiencies and reduce cycle time.

7. Communicate and negotiate label implementation with Regulatory Affairs and plant Operations.

8. Participate on project teams representing Label Control for new product launches, labeling related projects, and/or new package designs.

9. Ability to interpret governmental regulations and have a basic understanding of the requirements for pharmaceutical and animal health product labeling.

10. Assist Marketing, as required, in the development of label designs for packaging commodities.

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