Sr. Publishing Specialist
1 yr Contract – NJ
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, CRFs and eCRF 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).
Minimum of 3 – 4 years experience in Regulatory Affairs publishing and reviewing the documents
in a pharmaceutical environment, with strong familiarity with regulatory eCTD submission process.
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
Knowledge in scanning document.
Knowledge in FDA & ICH Guidance’s
Must be able to do multi-task and work well under tight timeliness.
Company offers very competitive hourly rate for contract role.