Release File Preparation Specialist | Release File Preparation Specialist | M/W/D - Referenz 001098

Job Summary

This role involves specialized work within a clinical study team at an internationally successful pharmaceutical company. The specialist is primarily responsible for compiling release documentation, including creating the Supply Chain Document, selecting appropriate release scenarios, and ensuring all relevant documentation is provided on time. Key responsibilities also include independently representing team activities, scheduling within clinical study teams while adhering to legal and regulatory frameworks, and evaluating risks to develop improvement proposals. The specialist will also act as a Subject Matter Expert (SME) in various innovation projects, actively contributing ideas for process improvement, and supporting internal inspections by providing documentation and presenting processes. Candidates should have a Master's or Bachelor's degree in natural sciences with relevant professional experience, particularly in GMP-regulated environments, and possess strong communication skills in both German and English.