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Experiences

Current Experience

  • Manager of the Document Management and Publishing Team


    Since February 2009
    • implementation of new processes and tools (isipublisher, isi ectdxpress, isitoolbox) for the publishing of Marketing authorisation dossiers, and the implementation of the eCTD (electronic common technical document). creation of associated trainings;
    • in charge of the Document Management of the submission documents and dossiers submitted to the authorities;
    • implementation of the eCTD for canada, switzerland, gcc countries (bahrain, kuwait, oman, qatar, saudi arabia, and the united arab emirates);
    • implementation of the authorities gateways (EMA gateway and gateway client developed internally, cesp);
    • implementation of an archiving and viewing solution for eCTD submissions (rosetta pyramid);
    • implementation of eCTD validators (extedo eurs validator and lorenz evalidator).
    • Implementation of new processes and tools (ISIPublisher, ISI eCTDXPress, ISIToolBox) for the publishing of marketing authorisation dossiers, and the implementation of the eCTD (electronic common technical document). Creation of associated trainings;
    • In charge of the document management of the submission documents and dossiers submitted to the authorities;
    • Implementation of the eCTD for Canada, Switzerland, GCC countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates);
    • Implementation of the authorities gateways (EMA Gateway and gateway client developed internally, CESP);
    • Implementation of an archiving and viewing solution for eCTD submissions (Rosetta Pyramid);
    • Implementation of eCTD validators (Extedo EURS Validator and Lorenz eValidator).

Past Experience

  • EU Publishing Team

    August 2006 --- January 2009
    • setting up of the publishing unit for the Marketing authorisation dossiers in europe, middle east, africa, turkey and russia;
    • management of the publishing and of the publishing plannings;
    • Document Management of the published dossiers;
    • bms delegate within the eCTD efpia group.

  • Publisher and Project Manager for e-Submissions

    July 2001 --- July 2006
    • global regulatory systems and technology group – Project Manager
      projects related to electronic publishing and the electronic dossier (within ucb and with the emea and efpia, Member of the efpia – eCTD topic group):

      • implementation of the common technical document (ctd) format at ucb.
      • implementation of coredossier (liquent) at ucb, for the publication of the submissions dossiers.
      • XML: pim (product information management in europe) and FDA.gov/oc/datacouncil/spl.HTML">spl (electronic labeling in the united states) projects, electronic application form.
      • eCTD/">eCTD (electronic common technical document).

       

    • regulatory Associate /Document Management and publishing

      • publishing of regulatory dossiers for european and international submissions, variations, answers to questions from the authorities, drug master file, Clinical Trial exemption and for periodic safety update reports.
      • organization and management of electronic archiving for the submitted dossiers with documentum.

  • IT and Network Adminstrator

    July 1999 --- July 2001
    • implementation and administration of a local area network (intranet) and of a library management system (alexandrie – g.b. concept).
    • daily maintenance of computers and network (repair and upgrading).
    • staff and students Training (search on the Internet, use of the computers).

  • Documentalist

    January 1998 --- June 1999
    • setting up of an electronic Document Management service at the financial co-ordination center of the bongrain group in brussels.
    • on-line database and Internet Research, preparation of information dossiers.

  • Freelance translator

    January 1994 --- December 1997
    Translation, revision and Editing of books for a publishing house (English, dutch, spanish and italian into French)

Knowledge

LinkedIn Assessment :
eCTDPublishingDocument ManagementRegulatory submissionsDocumentumNeeSProject ManagementComputer System ValidationChange Control21 CFR Part 11Pharmaceutical IndustryGXPRegulatory affairsRegulatory RequirementsPharmacovigilanceFDAValidationQuality AssuranceSOPVaccines

Education

  • Licence in Information and Document Management from Université libre de Bruxelles in 1998
  • LIcence in Communication (Journalism) from Université catholique de Louvain in 1990
  • Licence in History from Université Paris-Sorbonne in 1988
  • DEUG in History from Université Robert Schuman (Strasbourg III) in 1987
  • Baccalauréat in Philosophie, lettres, langues from Lycée Français de Belgique in 1984

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency
Dutch
Elementary Proficiency
Spanish
Elementary Proficiency
Italian
Elementary Proficiency

Work Preferences

  • Notice Period:
    13 weeks
  • Locations I am interested in:
    Belgium France Luxembourg
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Publications

    Expert has 2 publications (Will be avalible with full profile)

Area / Region

Nivelles, Belgium

Others

Driving License
  • Yes

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