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

New Jersey  ‐ Onsite
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Description

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

Experience:

-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.

To find out more about Real please visit www.realstaffing.com
Start date
02/2014
Duration
12 months
From
Real Staffing
Published at
18.02.2014
Project ID:
665010
Contract type
Freelance
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