TRD Composer Technical Service Specialist (m/f/d)

Aequor Consulting GmbH; Basel; On-site; CHF 110,000 - 170,000; Full time

Job summary

Aequor Consulting GmbH is seeking a technically skilled professional with proven experience in TRD Composer, regulatory documentation, and pharmaceutical data management. This role focuses on integrating and advancing regulatory IT systems while coordinating data governance in a highly regulated environment.

The ideal candidate will coordinate data governance activities, support interfaces between GSRS and TRD Composer, and ensure alignment of technical requirements with regulatory documentation

Qualifications

• Hands-on TRD Composer experience and understanding of its purpose and functionality.
• Regulatory processes and documentation in pharma, incl. GMP considerations.
• Knowledge of IDMP and ISO standards applied to digital regulated development.
• Understanding of IT systems, interfaces, data models and data governance.
• Experience with pharmaceutical substance data; GSRS familiarity is a plus.

Responsibilities

• Coordinate SUAM 3.0 implementation into TRD Composer with NVS IT Production.
• Set up GSRS and develop interfaces between GSRS and TRD Composer.
• Create and maintain the TRD reference data model for substance information.
• Coordinate the TRD Data Governance organization and data management processes.
• Coordinate technical implementations and system changes with IT and business stakeholders.
• Support change-related activities per IT documentation and change management processes.
• Ensure alignment between technical requirements and regulatory documentation needs.

Skills

TRD Composer experience

Regulatory documentation

Pharma data management

Data governance

Interfaces & data models

IT systems understanding

Tools

GSRS

Job description

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