Remote TRD Composer Tech Lead — Data Governance & Integration

OneSource Consulting; Switzerland; Remote; CHF 120,000 - 160,000; Full time

Job summary

OneSource Consulting is seeking an experienced TRD Composer Technical Specialist to support clients with technical implementation, substance data management and data governance in a fully remote, 12+ month engagement.

The role emphasizes coordinating IT production implementations, system integration, reference data models, and regulatory documentation requirements, with a focus on ISO standards, IDMP and pharma data governance.

Qualifications

• Proven knowledge of the purpose, design and functionality of TRD Composer.
• Understanding of pharmaceutical regulatory data and Health Authority documentation requirements.
• Knowledge of ISO standards and their application in development environments.
• Understanding of IDMP and its role in digital regulatory processes.
• Experience coordinating stakeholders and data governance activities.
• Experience leading and coordinating IT projects and teams.

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 for substance data exchange.
• Create and maintain the TRD reference data model and substance information stewardship.
• Coordinate activities across the TRD Data Governance organisation.
• Develop and maintain understanding of IT systems and applications related to TRD Composer.
• Provide technical oversight and support development and integration activities.
• Support ISO standards application in development environments.
• Contribute to IDMP-supporting digital processes.
• Support change-related activities in client IT processes.
• Collaborate with IT, data governance and business stakeholders to ensure delivery.

Skills

TRD Composer

Regulatory data

Data governance

ISO standards

IDMP

System integrations

Stakeholder coordination

Leadership

Job description

OneSource Consulting is seeking an experienced TRD Composer Technical Specialist to support clients with technical implementation, substance data management and data governance in a fully remote, 12+ month engagement.

The role emphasizes coordinating IT production implementations, system integration, reference data models, and regulatory documentation requirements, with a focus on ISO standards, IDMP and pharma data governance.