Remote TRD Composer & Data Governance Specialist

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

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.