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

Aequor Consulting; Basel; Remote; CHF 120,000 - 170,000; Full time

Benefits offered by this job

5 weeks of annual leave

Coverage of certification costs

Reka-Card with 20% discount up to CHF

CHF 400 fitness membership

Job summary

Aequor Consulting in Basel is seeking a TRD Composer Technical Service Specialist (m/f/d) with proven experience in regulatory documentation and pharmaceutical data management to drive IT system integration and data governance in a highly regulated environment.

You will coordinate SUAM 3.0 implementation, set up GSRS interfaces, maintain TRD data models, and align IT changes with regulatory needs while collaborating with IT and business stakeholders.

Qualifications

• Hands-on experience with TRD Composer and understanding its purpose, design and functionality.
• Experience with regulatory processes and documentation requirements in the pharma industry, GMP knowledge.
• Knowledge of IDMP standards and ISO standards in digital processes within regulated environments.
• Understanding of IT systems, interfaces, data models and data governance.
• Experience with pharmaceutical substance data; GSRS familiarity is an advantage.
• Knowledge of IT documentation and change management in regulated pharma environments.
• Strong technical understanding and ability to follow programming concepts and system integration requirements.
• Excellent English communication with coordination and leadership capabilities.

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 IT and business stakeholders.
• Support change-related activities per IT documentation and change management processes.
• Ensure alignment between technical system requirements and regulatory documentation needs.

Skills

TRD Composer

Regulatory documentation

Pharma data management

Data governance

IT systems & interfaces

Data modelling

GMP knowledge

IDMP standards

English communication

Leadership capabilities

Tools

GSRS

Job description

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

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
  
• 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