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Aequor Consulting GmbH

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

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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 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 membershipj4id10449074jm j4it1043jm j4iy26jm

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