A Labeling Associate contract assignment in Princeton, NJ 08540 is available through Adecco. This position serves as a highly skilled consultant for a 12 month full-time contact job anticipated to start immediately.
The Label Associate will prepare, review, approve and manage labeling for pharmaceutical products for FDA submission in accordance with FDA regulations.
Responsible for the creation of pharmaceutical labeling drafts for submission to FDA based on Reference Listed Drug labeling, FDA requirements and Sandoz requirements.
Responsible for the creation of labeling in SPL and PLR 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.
5-8 Years Pharmaceutical Labeling Experience
Ability to work under tight deadline pressure and handle multiple projects.
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 have a meticulous eye for details.
If you are interested in this Labeling Associate then please APPLY NOW. For other opportunities available at Adecco go to www.adeccousa.com. If you have questions about the position please contact Angela Painter at Angela.Painter@adeccona.com or by phone at 631-844-7037.
Important information: This position is being recruited for by Adecco's National Recruitment Center, not your local Adecco Branch Office. To be considered for this position, you must use the "apply now" button to submit your resume. If you have questions about the position, you may contact the recruiter recruiting for this position listed above; however your resume must be received via the "apply now" button included within to be considered.
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