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

Aequor Consulting GmbH; Basel; On-site; CHF 120,000 - 160,000; Full time

Benefits offered by this job

Remote Job

5 weeks of annual leave

Coverage of certification costs

Reka-Card with 20% discount on up to 2

CHF 400 contribution towards fitness

Job summary

Unknown client in pharmaceutical IT seeks a technically skilled professional with proven TRD Composer experience and regulatory data management expertise. The role focuses on integrating regulatory IT systems, governing data, and coordinating cross-functional activities in a highly regulated environment.

You will drive interfaces between GSRS and TRD Composer, create substance data models, and lead data governance initiatives while aligning IT changes with regulatory requirements.

Qualifications

• Proven hands-on experience with TRD Composer and its purpose, design and functionality.
• Experience with regulatory processes and GMP-type documentation in pharma.
• Knowledge of IDMP and ISO standards in digital regulatory workflows.
• Understanding of IT systems, interfaces, data models and data governance.
• Experience with pharmaceutical substance data; GSRS familiarity is a plus.
• Knowledge of IT documentation and change management in regulated pharma.
• Strong English communication, coordination and leadership capabilities.

Responsibilities

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

Skills

TRD Composer

Regulatory documentation

Data governance

IT systems

Interfaces & data models

Stakeholder coordination

Leadership

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
• Strong technical understanding and the ability to follow programming concepts and system integration requirements
• Excellent English communication skills, with strong coordination, stakeholder management and leadership capabilities

Benefits

• Remote Job
• 5 weeks of annual leave
• Coverage of certification costs
• Reka-Card with a 20% discount on up to CHF 2,400
• CHF 400 contribution towards a fitness membership