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ELECTRONIC SUBMISSIONS SPECIALIST (REGULATORY OPERATIONS EUROPE)
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| Titre |
ELECTRONIC SUBMISSIONS SPECIALIST (REGULATORY OPERATIONS EUROPE) |
| Description |
Key Responsibilties: - Experience of document management technology and electronic publishing software. - Responsible for the compilation and publishing of regulatory submissions using electronic publishing software or paper-based system. - Process electronic files incorporating bookmarks, hyperlinks, tabs and other formatting requirements. - Using electronic publishing tools to compile and publish electronic regulatory submissions (e.g., clinical trial applications, briefing books, Marketing Authorisation Applications). - Contributing to the development, implementation and support of regulatory publishing systems in Europe. - Developing and implementing e-templates for European submission documents. - Assisting in the dispatch of regulatory submissions in electronic format. - Assisting in the review and maintenance of relevant guidelines and SOPs. - Working closely with the Regulatory Operations Group in Summit, USA, to ensure consistent methods of filing and publishing. - Archiving of European regulatory documents within electronic document management system (e-sub Live Link). - Assist and support Regulatory team on any other activities related to the above. Your Profile: - Possess university degree or higher in the Life Sciences. - Prior experience in data management within the pharmaceutical sector. - Possess excellent technical competence. - Ability to work individually as well as in a team. - Possess excellent administrative skills, attention to detail and to deliver within the timeline. - Ability to communicate effectively in a multi- cultural and multi functional-environment. MICHAEL PAGE CONTACT : Your application will be sent to Terence O'Hare (Zurich Office), please quote the job reference KTOH19625 Our client is a top biopharmaceutical company focussed on improving healthcare through innovative and effective drug development. They are currently looking for an Electronic Submissions Specialist (Regulatory Operations Europe). |
| Pays |
France |
| Date de publication |
19 juin 2007 |
| Société ou Annonceur |
Michael Page |
| secteur activité |
Biotechnologies |
| Qualification |
International |
| Type de contrat |
CDI |
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