Technical Regulatory Document Specialist (Technical Writer)

Randstad IT Professionals is actively seeking a Technical Regulatory Document Specialist (Technical Writer) for one of our major clients in Basel, Switzerland

TASKS: 

- Prepares and updates technical regulatory documents according to instructions and ensures adherence to applicable regulatory (eg, CTD).
- Formats detailed data tables and figures and applies document formats using customized Word templates.
- Compiles regulatory dossiers and formats them for publishing.
- Maintains regulatory documents in document-management systems (eg, Documentum) and document-sharing systems (eg, SharePoint).
- Collaborates with regulatory product managers and with internal partners (eg, regulatory publishing)

QUALIFICATIONS:

- Good scientific background (eg, minimum education as labor specialist or BA/BS (or equivalent) in chemistry, biology or pharmacy).
- Previous experience with regulatory documents and dossier structures (eg, CTD ) or in the biotech or pharmaceutical industry is beneficial.
- Proficiency in a broad range of IT skills, including expert-level use of Word, Excel, and Acrobat and experience with document-management systems (eg, Documentum) and document-sharing systems (eg, SharePoint). Knowledge of publishing systems and requirements is beneficial.
- Tenacious attention to detail and consistency, especially with respect to style, format, and layout and ability to format technical documents using electronic tools.
- 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.

LANGUAGES:

Ability to communicate clearly and professionally, both orally and in writing, in English and German.