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Labeling Associate Job

Eingestellt von Yoh

Gesuchte Skills: Client

Projektbeschreibung

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

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Labeling
- FDA Submissions
- FDA Regulations

WHAT YOU'LL BE DOING:

- 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:

- Three (3+) years of Pharmaceutical Labeling Experience.
- SPL, Word, Excel, and PowerPoint.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Kara Lloyd

Yoh, a DayJ2W: CLINICAL; J2W: PROF

MONJOBJ2WNECLIN

Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    Princeton, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung

  • Skills:

    client

Yoh