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

Pharmaceutical R&D | 12-Month Contract | Switzerland / Cross-Border EU

Are 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 Responsibilities

Data Governance / Regulatory Systems Lead for pharmaceutical product data.

You will:

Coordinate IT changes and implementations

• Help roll out SUAM 3.0 into TRD Composer.
• Work with IT, business and regulatory teams.

Manage pharmaceutical substance data

• Set up connections between systems such as GSRS and TRD Composer.
• Ensure substance information moves correctly between platforms.

Own the data model

• Define how substance information should be structured and governed.
• Act as data steward.

Lead governance activities

• Coordinate data governance forums and stakeholders.
• Ensure quality and compliance of regulatory data.

Support regulatory documentation

• Ensure data supports submissions to Health Authorities and GMP documentation.

Systems Implementation

Coordinate 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 & Qualifications

• TRD 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 Eligibility

• Contract 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.com

Marina Economidou, Executive Solutions Consultant