TRD Composer Technical Specialist

This is a remote position.

About the Role

We are looking for an experienced TRD Composer Technical Specialist to support us with technical implementation, substance data management, system integration and data governance.

This role will involve coordinating IT production implementation activities, supporting the integration of substance information systems, developing reference data models and working with stakeholders to support regulatory and pharmaceutical documentation requirements.

The ideal candidate will combine strong TRD Composer knowledge with an understanding of pharmaceutical regulatory data, technical development environments and data governance.

Key Responsibilities

• Coordinate the implementation of SUAM 3.0 into the TRD Composer production environment.
  
• Support the setup of a facsimile GSRS application and develop system interlinks to facilitate substance data exchange.
  
• Create and maintain the TRD reference data model, taking responsibility for substance information stewardship.
  
• Coordinate activities across the TRD Data Governance organisation.
  
• Develop and maintain an understanding of the IT systems and applications associated with TRD Composer.
  
• Provide technical oversight and support development and integration activities.
  
• Support the application of relevant ISO standards within technical development environments.
  
• Contribute to the implementation of IDMP-supporting digital processes.
  
• Support change-related activities in accordance with our IT documentation processes.
  
• Collaborate with IT, data governance and business stakeholders to ensure effective delivery.
  

Requirements

Essential Skills and Experience

• Proven knowledge of the purpose, design and functionality of TRD Composer.
  
• Understanding of pharmaceutical business processes and data requirements for Health Authority and/or GMP documentation.
  
• Knowledge of relevant ISO standards and their application in technical development environments.
  
• Understanding of IDMP and its role in supporting digital regulatory processes.
  
• Familiarity with IT documentation processes and change-related activities.
  
• Understanding of IT systems, applications, programming concepts and system integrations.
  
• Experience coordinating stakeholders and technical or data governance activities.
  
• Strong English-language communication skills.
  
• Demonstrated leadership, organisation and coordination capabilities.
  

What We Are Looking For

We are seeking a technically capable professional who can quickly understand the TRD Composer environment, coordinate implementation activities and support the effective management and exchange of substance information.

Please note: Direct, proven knowledge of TRD Composer is a mandatory requirement for this position.