Regulatory Affairs Documentation Specialist (m/f)

REFERENZNUMMER:

350859/11

IHRE AUFGABEN:

-Ensure technical documentation support by preparation and formatting of scientific documents;

Maintenance of documents in the document management system; compilation of submission Dossiers, hand-over to publishing team -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)
-Collaborate with regulatory product managers and with internal partners

IHRE QUALIFIKATIONEN:

-Good scientific background (e.g. minimum education as laboratory assistant 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)
-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