US-NJ, PV Publishing Specialist
The role of the contractor(s) will be PV Publishing Specialist as a part of the PV Publishing team which only specializes in the publishing aspects of the previous job description.
Serve as specialist responsible for ensuring electronically compliant PV reports
Actively contribute to the development and implementation of improved 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.
Computer literacy especially in Windows based programsAbility to effectively troubleshoot issuesAbility to prioritize and multitaskExcellent communication skillsStrong attention to detail and interpersonal skills within or outside department
Previous experience working on PSRsWorking knowledge of ICH guidelines concerning the production and submission of PSURs and of EU Clinical Trial DirectivesDocument Management System experience and trainingCore Dossier Training
BA or BS preferred4 - 6 years of Pharma or related experience in document support/coordinationactivitiesUnderstanding of technologies involved (specifically Advanced MSWord/MSExcel, Documentum, Core Dossier, Insight Publisher and Acrobat)
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