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Regulatory Publisher Job

Eingestellt von Yoh

Gesuchte Skills: Adobe, Client

Projektbeschreibung

SENIOR REGULATORY PUBLISHER needed for a LONG-TERM CONTRACT opportunity for Yoh's client located in Woodcliff Lake, NJ.

WHAT YOU'LL BE DOING:

- The Senior Publishing Specialist will be part of the Regulatory Operations Publishing Group and to ensure that dossier is prepared ready to submit to the FDA and other agencies. This includes, Publishing(Bookmarking and Hyperlinking) and Peer Reviewing different types of document like (eg Clinical Study Report, Annual Report, Protocol, Amendments, PSUR, DMF, IMPD, Pre-Meeting packages, Labeling)
- Knowledge in building different types of submission
- Peer Reviewing of other group members' documents
- Experience in publishing the documents globally
- Knowledge in preparing Paper submission, scanning documents and Printing Desk copies (Internal or Health Authority)
- Experience in formatting documents as per company's standards

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's degree preferred
- Minimum of five to seven (5-7) years of pharmaceutical industry experience in a regulatory publishing role
- Must be highly proficient in Microsoft office, Adobe Acrobat, ISI writer and ISI Toolbox (with proven background in bookmarking and Hyperlink, page stamp, masking and watermarks etc.).
- Knowledge of eCTD submission eCTD Validator, eCTD Viewer and Life Cycle Management
- Experience in using different application like viewpoint, Coredossier or eCTDExpress etc

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Tonya Allen

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

Projektdetails

  • Einsatzort:

    Woodcliff Lake, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung, Medien/Design

  • Skills:

    adobe, client

Yoh