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Technical Regulatory Document Specialist


  • A hirdetés 815 napja lejárt
Kelly Scientific Resources (KSR), a division of Kelly Services, is the worldwide leading provider of scientific personnel. Our team in Basel (Switzerland) consists of experts with a solid background in chemistry, pharmacy or biotechnology, as well as several years of consultancy experience.
For our customer, an internationally leading pharmaceutical company with headquarters in Basel, we are looking for a motivated
Technical Regulatory Document Specialist
The Pharma Technical Regulatory (PTR) Document Specialist in the Submission Support Group provides technical documentation support for submission generation activities. His or her tasks include the following: preparation and formatting of regulatory documents, maintenance of regulatory documents in the document management system, compilation of submission dossiers, and preparation for publishing. In addition, he or she provides limited support to the PTR product managers for the systems and tools used for submission-generation processes
Responsibilities
- Prepares and updates technical regulatory documents according to instructions and ensures adherence to applicable regulatory (e.g., CTD) and the customers documentation standards.
- Applies document formats using customized Word templates, and formats detailed data tables and figures.
- Imports documents into document-management systems (e.g., Documentum)
- Maintains regulatory documents in document-management systems (e.g., Documentum) and document-sharing systems (e.g., SharePoint).
- Collaborates with regulatory product managers and with internal partners (e.g., regulatory publishing)

Required experience, skills, and education
- Good scientific background (e.g., minimum education as labor specialist or BA / BS (or equivalent) in chemistry, biology or pharmacy).
- Proficiency in a broad range of IT skills, including expert-level use of Word, Excel, and Acrobat and experience with document-management systems (e.g., Documentum) and document-sharing systems (e.g., SharePoint).
- Tenacious attention to detail and consistency, especially with respect to style, format, and layout and ability to format technical documents using electronic tools.
- Previous experience with regulatory documents and dossier structures (e.g., CTD ) or in the biotech or pharmaceutical industry is beneficial.
- Ability to communicate clearly and professionally, both orally and in writing, in English and German.
- An aptitude for teamwork and the ability to interface effectively with colleagues located in other countries and sites.
- Strong organizational and time-management skills; the ability to deliver under pressure; and the ability to work flexibly to support changing assignments and priorities in an independent and reliable manner.
Further Informations
Level of employment: 100%
Beginning: September
Service duration: about 4 months (might be extended )
Place: Basel

Please send your complete application (CV, reference letters, diplomas) to Claudia Hudson () or to Kelly Scientific Resources, zH. Frau Hudson, Postfach 326, Clarastrasse 12, 4005 Basel.
Region: Basel
Vertragsart: Befristet
Kategorie: Naturwissenschaft/Forschung
Veröffentlicht am: 31.07.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1407-12874
Abteilung: Kelly Services, Inc. in Switzerland is a leader in providing innovative workforce solutions. Kelly offers a comprehensive array of custom-designed outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and permanent basis. Kelly provides employment to more than 200 people in over 40 branches and specialist department throughout Switzerland.

Kelly specializes in providing professional/technical workforce solutions, with local expertise. These solutions include Finance, Science, and Medical. Kelly has a rich history in developing our solutions to address the workforce challenges of these communities, with expert staff dedicated to providing integrity and technical competency to ensure high performance, and proven results from its specialty talent.Link megjelenítése" width="0" height="0" />
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