TRD Composer Technical Lead

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

Duration: 12+ months (extendable with a strong possibility of extension depending on business needs).

Work type: Fully remote

Start date: 1st Week of Jan 2027

About the Role

We are looking for an experienced TRD Composer Technical Specialist to support client 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 client IT documentation processes.

Collaborate with IT, data governance and business stakeholders to ensure effective delivery.

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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 Client 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.

Demonstrated leadership, organisation and coordination capabilities.