You will coordinate the implementation of SUAM 3.0 into TRD Composer and manage the integration of GSRS applications. Additionally, you will oversee TRD data governance and ensure technical system requirements align with regulatory documentation needs.
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.
Responsibilities
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
Requirements
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
Strong technical understanding and the ability to follow programming concepts and system integration requirements
Excellent English communication skills, with strong coordination, stakeholder management and leadership capabilities
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