Specialist Regulatory Information and Document Management

On behalf of our successful client we are looking for a regulatory area support in Darmstadt asap for 20h per week.
Organization Description
• Provides statistical, clinical data management and programming for the medical department. Collaborates in the production of the study protocols, provides and/or facilitates sample size calculations. Reviews case report forms (CRFs) to ensure appropriate data collection, leaning, statistical analysis and reporting of the study. Enhances understanding of statistical hypothesis testing and presentations.
• Responsible for storage, retrieval and business administration of the Global Regulatory electronic archiving system
• Responsible for the on-site and off-site paper archives of Global Regulatory in Darmstadt, including overseeing the storage and retrieval of documents and coordination of paper archives at other global sites, incl. US
• Oversees / ensures maintenance and business support of the systems he/she is accountable for Supports the selection and implementation of new solutions, systems and enhancements for GR&QA

Qualifikationen
• Degree or development in technical and/or pharmaceutical field, or equivalent
• Fluent command of spoken and written English
• Excellent knowledge of German depending on location
• Four years experience in pharmaceutical industry, or equivalent
• Extensive knowledge of electronic document management, archiving and publishing technology
• Experience in managing paper archives
Please forward your CV to Tom Sander or via our web application system at www.randstad.de or by Mail. If you have any further questions please do not hesitate to contact Tom Sander.
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