Specialist, Release File Preparation | Spezialist m/w/d für die Vorbereitung von Release-Dateien 5183€ plus Prämien

Job Summary

This Specialist role is situated within a clinical study team in the pharmaceutical industry, focusing on the critical task of independently compiling and preparing release documentation (Release Files). The position requires serving as the primary representative for Clinical Trial Manufacturing and Release File Preparation (CTM RFP) activities within clinical study teams, ensuring strict adherence to all legal and regulatory requirements, particularly GMP standards. Key responsibilities also include evaluating risks, developing and implementing process improvements, and acting as a Subject Matter Expert (SME) in various innovation projects. Successful candidates must have a strong background in natural sciences, substantial experience in GMP-regulated pharmaceutical development, and excellent communication skills in both German and English.