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

Job Summary

As a Release File Preparation Specialist, you will play a crucial role within clinical study teams, independently compiling release documentation for pharmaceutical products. Your responsibilities will extend to representing and managing Clinical Trial Manufacturing/Release File Preparation (CTM RFP) activities and timelines, ensuring strict adherence to legal and regulatory guidelines. You'll also be instrumental in evaluating risks, developing improvement proposals, and acting as a Subject Matter Expert in various improvement and innovation projects. Additionally, you will support internal inspections by providing necessary documents and presenting processes from your area of responsibility. This position requires a strong background in natural sciences, experience in GMP-regulated environments, and excellent communication skills in both German and English.