Regulatory Affairs Documentation Specialist (m/f)

REFERENZNUMMER:

248361/11

IHRE AUFGABEN:

-Prepare and update technical regulatory documents according to instructions and ensure adherence to applicable regulatory (e.g. CTD) and the clients documentation standards
-Apply document formats using customized Word templates and format detailed data tables and figures
-Import and maintain documents in document management systems (e.g. Documentum) or document-sharing systems (e.g. SharePoint)
-Collaborates with regulatory product managers and with internal partners

IHRE QUALIFIKATIONEN:

-Good scientific background (e.g. minimum education as labor specialist or BA/BS (or equivalent) in chemistry, biology or pharmacy)
-Excellent command 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 regulatory documents using electronic tools
-Previous experience with regulatory documents and dossier structures (e.g. CTD ) or in the biotech or pharmaceutical industry is beneficial

WEITERE QUALIFIKATIONEN:

Regulatory affairs assistant