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Labeling Associate Job
Eingestellt von Yoh
Gesuchte Skills: Client
Projektbeschreibung
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
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Einsatzort:
Princeton, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung