Regulatory Affairs Associate - Proofreader Job

REGULATORY AFFAIRS ASSOCIATE - PROOFREADER needed for a CONTRACT opportunity with Yoh's client located in MELVILLE, NY.

WHAT YOU'LL BE DOING:

- Reviews, edits and approves all assigned project deliverables against project documentation and specifications prior to client delivery.
- Inspects drafts, layouts, edited copy and vendor proofs to make sure that the final text and/or graphics are complete and accurate, and ensures that spelling, grammar and punctuation are correct.
- Traffic packaging component items and routes approvals through various departments using Documentum Compliance Manager. Must have a strong sense of urgency and understanding of multiple priorities.
- Utilize Global Vision System (Digital Page and Docu-Proof) to conduct automated inspections on component labeling.
- Review graphic/text placement in regard to template image areas, lot/exp and bar codes.
- Facilitate Change Control processes to ensure required changes to component labeling have been completed and approved. This includes, proofing and trafficking through Documentum as well as documenting closure of Change Controls when Nova process is complete.
- Correspond effectively with outside vendors on status of art files, proofs and deliverable time lines.

WHAT YOU NEED TO BRING TO THE TABLE:

- Associate degree, Bachelors preferred.
- Must possess an excellent command of language with strong client/product knowledge be familiar with FDA regulations regarding Rx drug labeling.
- Ability to work under tight timeline pressure, handle multiple projects, ability to pay close attention to detail.
- Must have excellent communication, organizational skills, and a meticulous eye for details.
- Must have working knowledge of color prepress requirements and the printing process Prior experience in proofreading required
- Must know PC based software including: Word, Excel, PowerPoint, Outlook
- Must be capable of learning and adapting to new software programs such as Documentum Compliance Manager, Global Vision and WebScan.
- Prior experience in pharmaceutical or related industry a plus.

WHAT'S IN IT FOR YOU?

- This is a wonderful opportunity for you to play an integral role at a growing site within one of the largest and most respected pharmaceutical companies in the world.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Kathy Pavlick

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