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

Job Summary

This specialist role focuses on managing the critical documentation lifecycle for clinical trial materials (CTM). You will be responsible for the independent creation and compilation of comprehensive release documentation for clinical studies, ensuring strict adherence to all regulatory guidelines and project timelines. A core aspect of the position involves representing CTM-RFP activities within study teams, assessing potential risks, and actively developing proposals for process improvements within the documentation and release workflows. The ideal candidate must possess a completed scientific degree (Master or Bachelor with relevant experience) or an advanced technical qualification (Meister/Techniker), coupled with several years of professional experience in the pharmaceutical industry. Initial experience in GMP-regulated areas and proficiency in MS Office and SAP-based systems are essential. This position offers the opportunity to act as a Subject Matter Expert in innovation projects and requires proactive, goal-oriented communication in both German and English.