Senior Publisher (ectd/ectdxpress/ISI toolbox/Submissions)

Job type:
Start date:
12 months
Real Staffing
New Jersey
Published at:
flag_no USA
Project ID:

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I have a Senior Publishing (ectd/ ectdxpress / Submissions) Contract position for a pharmaceutical client based in New Jersey. The regulatory publisher will have responsibility for the compilation and publishing of all global regulatory submission types (including eCTD, NeeS, Global Dossier, paper etc.)
The role and expertise required:

-Publishing(Bookmarking and Hyperlinking)

-Peer Reviewing different types of document (eg Clinical Study Reports, Annual Report, Protocol, Amendments, PSUR, DMF, IMPD, CRFs and eCRF Pre-Meeting packages, Labeling)

- Building different types of submission.

-Knowledge of eCTD submission eCTD Validator, eCTD Viewer and Life Cycle Management
-Experience in using different application like viewpoint, Coredossier or eCTDExpress etc

- An expert in Microsoft office, Adobe Acrobat, ISI writer and ISI Toolbox


-3-5 years experience in Regulatory Publishing ( for a pharma)

-Proven track record in the regulatory eCTD submission process.

The contract is for 12 months (possible 3 years) and the client has a flexible working pattern. If you are interested, please send across an up to date resume and I will give you a call.

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