Job Title: PV Publishing Specialist
Job ID: 8279760
Location: Bridgewater, NJ
Duration: 5 Months
The role of the contractor(s) will be PV Publishing Specialist as a part of the PV Publishing team which specializes in publishing. Publishing / documentation experience is needed.
Serve as specialist responsible for ensuring electronically compliant PV reports
Actively contribute to the development and implementation of improved client PV report processes as appropriate.
Support the review, QC, approval and notification process of reports published in DOMASYS.
Provide DOMASYS/DOMEX and publishing support for all PV reports to include RMP, Adhoc Safety Reports, PSMF publishing.
Act as DMS expert for eCTD, PV report publishing, DOMASYS Template coordination, other report publishing related projects
Responsible to deliver on time published reports to PSR customers in required format. This involves troubleshooting issues raised by DMS, and providing ad hoc user support to GPE collaborators in the use of DMS and advanced features of MSWord.
Ensure tasks and activities are performed according to the Work Instructions, procedures and policies in place.
Participate in the writing / updating of quality documents related to PV Publishing activities.
Previous experience working on PSRs
Working knowledge of ICH guidelines concerning the production and submission of PSURs and of EU Clinical Trial Directives
Document Management System experience and training
BA or BS preferred
4 - 6 years of Pharma or related experience in document support/coordination activities
Understanding of technologies involved (specifically Advanced MSWord/MSExcel, Documentum, Core Dossier, Insight Publisher and Acrobat)
Artech Information Systems