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Pharmaceutical Data Governance Consultant (TRD Composer or Regulatory IM Systems)- Exciting long project

Templeton & Partners - Innovative & Inclusive Hiring Solutions · Zurich, Switzerland

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Pharmaceutical R&D | 12-Month Contract | Switzerland / Cross-Border EUAre you an experienced pharmaceutical IT and data governance specialist with expertise in substance reference data, regulatory standards and R&D systems integration?A leading international pharmaceutical organisation is seeking a TRD Technical Service Specialist to support global Technical Research & Development (TRD) operations. You will take ownership of substance information governance, coordinate system implementations and enable reliable data exchange across critical R&D platforms in a highly regulated environment.This is a 12-month contract opportunity (remote/hybrid working available; with possible extensions) for a specialist who can bridge technical IT delivery, pharmaceutical data standards and regulatory requirements.€211,200 gross contract value (based on 1,920 hours)Key ResponsibilitiesData Governance / Regulatory Systems Lead for pharmaceutical product data.You will:Coordinate IT changes and implementationsHelp roll out SUAM 3.0 into TRD Composer.Work with IT, business and regulatory teams.Manage pharmaceutical substance dataSet up connections between systems such as GSRS and TRD Composer.Ensure substance information moves correctly between platforms.Own the data modelDefine how substance information should be structured and governed.Act as data steward.Lead governance activitiesCoordinate data governance forums and stakeholders.Ensure quality and compliance of regulatory data.Support regulatory documentationEnsure data supports submissions to Health Authorities and GMP documentation.Systems ImplementationCoordinate the production implementation of Substance Administration Module (SUAM 3.0) functionality within TRD Composer environments.Systems Integration: Establish and maintain integrations with the Global Substance Registration System (GSRS), including the configuration of facsimile applications and substance data exchange interfaces.Substance Data Stewardship: Own and maintain substance reference data models, ensuring data quality, consistency and traceability across relevant R&D systems.Data Governance: Coordinate governance activities across Technical R&D teams, aligning business requirements, data ownership and system processes.Regulatory Data Standards: Support data management and digital processes aligned with ISO Identification of Medicinal Products (IDMP) standards.Change & Compliance Management: Coordinate IT change requests, technical documentation and implementation activities in accordance with established procedures and applicable GMP requirements.Stakeholder Collaboration: Work closely with IT, data management, regulatory and technical development stakeholders to deliver compliant, fit-for-purpose solutions.Essential Experience & QualificationsTRD Systems: Hands-on experience with TRD Composer or a comparable pharmaceutical R&D document and data composition platform.Substance Data & GSRS: Practical knowledge of substance registration, substance data management and the Global Substance Registration System (GSRS).ISO IDMP Standards: Understanding of pharmaceutical data standards, particularly ISO 11238 and ISO 11615, and their application to regulatory information management.GMP & Regulatory Compliance: Experience working in a regulated pharmaceutical environment, with knowledge of GMP requirements and Health Authority documentation processes.Technical & Functional Delivery: Ability to interpret technical specifications or programming logic, coordinate system interfaces and manage IT change requests.Data Governance: Experience with reference data models, data stewardship, data quality and cross-functional governance.Stakeholder Management: Confident coordinating discussions between technical teams, business stakeholders and data owners.Location & Contract EligibilityContract duration: 12 months renewable.

Location: Switzerland, with consideration for eligible cross-border commuters based in neighbouring regions of France or Germany.Work authorisation: Candidates must be eligible to work under the applicable Swiss employment or payroll arrangement.Interested?If you combine pharmaceutical R&D systems expertise with substance data governance and regulatory data standards, I’d welcome a confidential conversation.Please apply with your latest CV and send me directly your CV with all relevant experience, daily rate/gross annualised salary expectations, availability to interview and start:marina.economidou@templeton-recruitment.comMarina Economidou, Executive Solutions Consultant