Release File Preparation Specialist | Release File Preparation Specialist | M/W/D - Referenz 001009

consult16 GmbH

Biberach an der Riß, Baden-Württemberg, Deutschland
Published Aug 11, 2025
Full-time
Fixed-term

Job Summary

This role involves independently compiling release documentation within a clinical study team for an internationally successful pharmaceutical company. The specialist will represent and manage Clinical Trial Manufacturing/Release File Preparation (CTM RFP) activities and timelines, ensuring compliance with legal and regulatory requirements. Key responsibilities also include evaluating risks, proposing improvements, and acting as a Subject Matter Expert in various innovation projects. The ideal candidate will have a scientific background, experience in GMP-regulated pharmaceutical environments, and strong communication skills in both German and English. This is an excellent opportunity for a detail-oriented professional to contribute to clinical trial processes and continuous improvement initiatives.

Required Skills

Education

Master's degree in Natural Sciences, or Bachelor's degree in Natural Sciences, or Scientific vocational training with further qualification as Master or Technician

Experience

  • Professional experience in GMP-regulated environments within pharmaceutical development
  • Several years of relevant professional experience, preferably in the pharmaceutical industry (if Bachelor's degree)
  • Several years of professional experience (if scientific vocational training with further qualification)

Languages

German (Fluent)English (Fluent)

Additional

  • Initial 18-month fixed-term contract. Located in Upper Swabia, Germany. Reference number 001009 required for application.