TRD Composer Technical Service Specialist; m​/f​/d

For our client in the pharmaceutical industry, we are looking for a technically skilled professional with proven experience in TRD Composer, regulatory documentation and pharmaceutical data management
. In this role, you will play a key part in the integration and further development of regulatory IT systems, while coordinating data governance activities in a highly regulated environment.

• Coordinate the implementation of SUAM 3.0 into TRD Composer in collaboration with NVS IT Production
• Set up the GSRS application and develop interfaces between GSRS and TRD Composer to enable the exchange of substance information
• Create and maintain the TRD reference data model for substance information
• Coordinate the TRD Data Governance organization and support consistent data management processes
• Coordinate technical implementations and system changes with relevant IT and business stakeholders
• Support change-related activities in accordance with internal IT documentation and change management processes
• Ensure alignment between technical system requirements and regulatory documentation needs

• Proven hands-on experience with TRD Composer and a thorough understanding of its purpose, design and functionality
• Experience with regulatory processes and documentation requirements in the pharmaceutical industry, particularly health authority documentation and/or Good Manufacturing Practice (GMP)
• Knowledge of IDMP standards and relevant ISO standards, including their application in digital processes within a regulated development environment
• Understanding of IT systems, application interfaces, data models and data governance
• Experience working with pharmaceutical substance data; familiarity with GSRS is an advantage
• Knowledge of IT documentation and change management processes in a regulated pharmaceutical environment