We are currently seeking a Documentation Management Assistant (m/f/d) on behalf of our business partner in the pharmaceutical industry, located in Biberach .
Here's what we offer
1. Attractive salary and long-term job security through affiliation with a large corporation.
2. Up to 30 days of vacation per year
3. Company pension scheme contribution after the end of the probationary period
4. Extensive social benefits, including Christmas and holiday pay
5. Reimbursement of travel expenses
6. Usually an open-ended employment contract
7. Good opportunities for acquisition with our business partners
8. Tailored professional development opportunities and free language courses
9. A wide range of employee benefits
Your tasks
10. They are responsible for the independent organization, coordination, and timely processing of documents and reports within their department, using the relevant systems and ensuring compliance with GxP regulations.
11. In this role, you will manage the entire documentation process from creation to final approval, including the coordination of all workflows and the technical implementation.
12. Furthermore, you will be responsible for monitoring and continuously developing the existing template landscape by conceptualizing, creating, and optimizing templates, manuals, and best practices.
13. They introduce new employees to the processes of Documentation Management and act as the central contact person for all system and process-related questions, especially in connection with EDMS-for-Submission, GxP-compliant archiving of raw data and the formatting of documents.
14. Another key aspect of your role is the independent organization and ensuring of the proper archiving of raw data in accordance with GLP, GCP and non-GxP requirements, acting as the central point of contact for all archiving-related matters.
15. Furthermore, you will assume the key user function and first-level support for the relevant systems and coordinate the execution of IB QC checks for the CPS functions.
16. Your responsibilities are rounded out by researching publications and references, as well as applying for and managing reference numbers for different types of documents.
17. Furthermore, you will represent the department in audits and inspections.
Your profile
18. Completed commercial or scientific training with several years of professional experience, or training as a medical documentarian or comparable qualification with many years of professional experience in documentation management.
19. Several years of sound experience in the relevant processes and in dealing with the corresponding systems within the area of responsibility.
20. Experience in processing clinical and non-clinical documents or document parts is essential.
21. Excellent MS Office skills as well as a strong willingness and ability to quickly learn new systems.
22. Strong communication skills, service-oriented, and a friendly, confident demeanor paired with a high degree of reliability.
23. Fluent German skills and good English skills, both spoken and written.
24. Willingness to be regularly present on-site and to work closely with the team.