Labeling Associate Job

LABELING ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in PRINCETON, NJ.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Pharmaceutical labeling
- FDA submissions
- Regulatory requirements

WHAT YOU'LL BE DOING:

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

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelors degree
- Five to eight (5-8) Years Pharmaceutical Labeling Experience
- SPL, Word, Excel, PowerPoint
- 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.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

MONJOBJ2WMIDATL

Ref:

SFSF: LS