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Projektbeschreibung
REFERENZNUMMER:
360347/11
IHRE AUFGABEN:
-According to location, provide iTRACK user support for all members at HQ and different sites, who contribute documents for submission to competent authorities, including training or refresher training to users
-Provide electronic publishing support with regard to Word documents (insertion of Word hyperlinks, making hyperlinks blue, etc.) and PDFs (using ISIToolbox to ePublish documents for which the various components have been approved by the authors, or applying ePublishing to scanned documents)
-Uploading documents to iTRACK (either at the authoring stage of a document, e.g., protocols or appendices of a report, or at the final stage, e.g., scanned documents from external CROs)
-Provide format QC, reformatting to standards as required, and electronic approval as required, thus ensuring compliance of electronic documents with eCTD standards and requirements and publishability of the documents
-Work with DRA Operations to contribute to overall planning activities, including US-generated submissions
IHRE QUALIFIKATIONEN:
-Excellent Word & Acrobat skills
-Ability to communicate effectively in English (spoken and written)
-Committed attention to detail: accurate and meticulous
-Ability to work independently and under pressure (able to prioritize tasks, deadline oriented, good organizational and problem-solving skills, follow-up skills)
-Previous experience with electronic document management systems & publishing of eCTD submissions is an advantage
-Knowledge of XML and ISIToolbox would be an asset
WEITERE QUALIFIKATIONEN:
CRA
360347/11
IHRE AUFGABEN:
-According to location, provide iTRACK user support for all members at HQ and different sites, who contribute documents for submission to competent authorities, including training or refresher training to users
-Provide electronic publishing support with regard to Word documents (insertion of Word hyperlinks, making hyperlinks blue, etc.) and PDFs (using ISIToolbox to ePublish documents for which the various components have been approved by the authors, or applying ePublishing to scanned documents)
-Uploading documents to iTRACK (either at the authoring stage of a document, e.g., protocols or appendices of a report, or at the final stage, e.g., scanned documents from external CROs)
-Provide format QC, reformatting to standards as required, and electronic approval as required, thus ensuring compliance of electronic documents with eCTD standards and requirements and publishability of the documents
-Work with DRA Operations to contribute to overall planning activities, including US-generated submissions
IHRE QUALIFIKATIONEN:
-Excellent Word & Acrobat skills
-Ability to communicate effectively in English (spoken and written)
-Committed attention to detail: accurate and meticulous
-Ability to work independently and under pressure (able to prioritize tasks, deadline oriented, good organizational and problem-solving skills, follow-up skills)
-Previous experience with electronic document management systems & publishing of eCTD submissions is an advantage
-Knowledge of XML and ISIToolbox would be an asset
WEITERE QUALIFIKATIONEN:
CRA
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges