Release File Preparation Specialist | Release File Preparation Specialist (m/w/d)

Job Summary

This role involves the independent creation and compilation of release documentation for clinical studies, ensuring compliance with regulatory requirements and timelines. The specialist will represent CTM-RFP activities in study teams, assess risks, and propose improvements for documentation and release processes. They will also act as a Subject Matter Expert in improvement and innovation projects and support internal inspections by providing relevant documents and presenting processes. The ideal candidate will have a scientific background, experience in GMP-regulated pharmaceutical development, and proficiency in MS Office and SAP-based systems, demonstrating a proactive and reliable approach to work.