Remote TRD Composer Technical Specialist

Next-Link; Basel; Remote; CHF 120,000 - 180,000; Full time

Job summary

Next-Link is seeking an experienced TRD Composer Technical Specialist to support technical implementation, substance data management, system integration and data governance in a remote role based in Switzerland. The role involves coordinating IT production activities, integrating substance information systems and developing reference data models for regulatory documentation.

The ideal candidate combines TRD Composer knowledge with an understanding of pharmaceutical regulatory data, IT

Qualifications

• Proven knowledge of the purpose, design and functionality of TRD Composer.
• Understanding of pharmaceutical business processes and data requirements for Health Authority and 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 data governance activities.
• Demonstrated leadership, organisation and coordination capabilities.

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.

Skills

TRD Composer

Regulatory Data

ISO Standards

IDMP

IT Documentation

System Integrations

Stakeholder Coordination

Leadership

Job description

Next-Link is seeking an experienced TRD Composer Technical Specialist to support technical implementation, substance data management, system integration and data governance in a remote role based in Switzerland. The role involves coordinating IT production activities, integrating substance information systems and developing reference data models for regulatory documentation.

The ideal candidate combines TRD Composer knowledge with an understanding of pharmaceutical regulatory data, IT