Publisher Job

PUBLISHER needed for a CONTRACT opportunity with Yoh's client located in WOODCLIFF LAKE, NJ.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Experience in Regulatory Affairs publishing and reviewing the documents in a pharmaceutical
- Experience with documents including Clinical Study Report, Annual Report, Protocol, Amendments, PSUR, DMF, IMPD, CRFs and eCRF Pre-Meeting packages, Labeling

WHAT YOU'LL BE DOING:

- Involved in the Regulatory Operations Publishing Group and to ensure that dossier is prepared ready to submit to the FDA and other agencies.
- Responsible for Publishing (Bookmarking and Hyperlinking) and Peer Reviewing different types of document like (eg Clinical Study Report, Annual Report, Protocol, Amendments, PSUR, DMF, IMPD, CRFs and eCRF Pre-Meeting packages, Labeling)
- Responsible for Peer Reviewing of other group members' documents.

WHAT YOU NEED TO BRING TO THE TABLE:

- Knowledge in preparing Paper submission, scanning documents and Printing Desk copies (Internal or Health Authority).
- Experience in publishing the documents globally(MAA submission & Health Canada).
- Experience in Processing SAE's and OPDP submission
- Experience in formatting documents.
- 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(Lorenz and Global Submit), eCTD Viewer and Life Cycle Management
- Experience in using different application like viewpoint, Coredossier or eCTDExpress etc (TRS Publisher, TRS TRACKER and Document management systems like First Doc)
- Knowledge in scanning document, FDA & ICH Guidance's

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Chelsea Tevis

Yoh, a DayJ2W: SCIENTIFIC; MONJOB

TAX TERM: CON_W2 J2WMIDATL

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SFSF: LS