Clinical Trial Release Documentation Scientist | Naturwissenschaftler für Freigabedokumentation klinische Studien (m/w/d)
akut... Kompetente Lösungen GmbH
Job Summary
This role is based within a globally successful pharmaceutical company in Biberach, where you will serve as a Release File Preparation Specialist for clinical trial teams. Your primary responsibility involves the meticulous compilation of release documentation and the creation of supply chain documents. You will select appropriate release scenarios, ensure all relevant records are provided on time, and represent team activities within clinical trial meetings while adhering to legal and regulatory frameworks. Beyond documentation, you will evaluate risks, propose process improvements, and act as a Subject Matter Expert (SME) in innovation projects. This position is ideal for those who enjoy a mix of scientific oversight and administrative precision. It offers a structured 37.5-hour work week, a competitive salary package including performance bonuses, and the opportunity to work in a highly innovative GMP-regulated environment with a motivated team.
Required Skills
Education
Master's degree in Natural Sciences; alternatively, a Bachelor's degree with several years of relevant experience or a completed scientific vocational training with extensive professional experience.
Experience
- Professional experience in GMP-regulated environments such as pharmaceutical development or manufacturing
- Experience in the pharmaceutical industry is preferred
- Proven experience in independent project representation and scheduling within clinical study teams
- Experience working as a Subject Matter Expert (SME) in innovation projects and process optimization
- Several years of relevant professional experience required if applying with a Bachelor's degree or vocational training
Languages
Additional
- The role requires a high degree of reliability, flexibility, and the ability to support internal inspections by presenting processes and documentation. Location is Biberach, Germany.
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