Jérôme FOURET

Experience

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  Ipsen

  Jul 2007 - Jan 2016

  Publisher - Global Regulatory Operations

  Publishing of Marketing Authorisation Dossiers forCentralised, Decentralised, Mutual Recognition or NationalProcedure for Europe, Africa, Asia, Latin America andnorthern America, both for paper and electronic submissions.Document management, Core Dossier.Regulatory Operations representative during the SubmissionTeam meeting, to define the deadlines, and help authors torogress in the preparation of the documents.Provides Training and support for authors or users to theElectronic Document Management System and Databases and educates authors publishing rules and procedures.Implementation of new publishing tools: (ISIeCTDXPress) and new processes to publish dossier in Nees format (Non-eCTDelectronic Submissions).Development of reports (Business Object) for theextraction of data from an Oracle database (MISAMM).Working toolsDocument management: DocumentumPublishing tools:ISI eCTDXPress, ISI publisher, Ezsubs,ISI Toolbox (pour Adobe Acrobat)Submission checkers: eCTDChecker, EURSvalidator, BfArM eValidatorDatabase: MisAMM Show less

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  Roche (Hays contractor)

  Feb 2016 - Sept 2018

  RSG Coordinator/Publisher

  Working alongside the Publishing Lead in publishing a MAA Submission, and New IndicationCoordinating and Publishing of the Baseline Dossier for 4 productsLiaising with Project Managers to get submissions out correctly and in a timely mannerPublishing Submissions using various software applications LIQUENT InSight (IP), Documentum, Isitoolbox, Coordinating and publishing other Submissions Types.

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  Roche

  Oct 2018 - now

  Regulatory Submission Manager

  Provide coordination, compilation, publishing, and submission expertise in the preparation of new and existing regulatory applications.