Specialist Regulatory Information and Document Management Teilzei

Specialist Regulatory Information and Document Management Teilzeit (20 h)

On behalf of an international successful client in Darmstadt we are looking for a specialist for regulatory information and document management. The position is until the end of the year and extension is possible.

Tasks:
- 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, cleaning, 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
- Responsible for training coordination on the systems he/she is accountable for
- Acts as a Business Subject Matter Expert for the systems he/she is accountable for

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
• In addition to standard software applications (Microsoft Office, MS Project): Specialized software skills (e.g. in Oracle
- databases, SQL scripting, Electronic Document Ma