Data Product owner

Data Product Owner

Work mode - Hybrid -2 Days per week

Work Location – Stevenage, UK

Key Responsibilities:

Product Ownership:

• Own and prioritise the product backlog, defining clear user stories, acceptance criteria, and epics aligned to regulatory and business objectives

• Lead sprint planning, refinement, and review ceremonies as an active member of the Agile delivery team

• Define and communicate the product vision and roadmap to stakeholders at all levels

• Make informed trade-off decisions on scope, timelines, and quality

Data Centric Submissions:

• Drive the adoption and evolution of DCS principles including structured data (IDMP, ISO SPOR, FHIR), electronic Common Technical Document (eCTD), and machine-readable submission formats

• Collaborate with Regulatory Affairs to ensure submission data models meet agency requirements (EMA, FDA, MHRA, etc.)

• Work with data architects and engineers to define data standards, taxonomies, and validation rules for submission content

• Champion the transition from document-centric to data-centric regulatory processes

Stakeholder Management:

• Engage regularly with Regulatory Affairs, Medical Writing, Clinical Data Management, and IT teams to gather and refine requirements

• Present product updates and roadmaps to senior leadership and cross-functional partners

• Act as the primary point of contact for internal customers and key external partners

Continuous Improvement:

• Monitor industry trends in regulatory technology (RegTech) and evolving agency guidance on data submissions

• Identify opportunities to improve data quality, submission efficiency, and compliance

• Define and track KPIs and OKRs for product performance

Essential Skills & Experience:

• Proven experience as a Product Owner or Product Manager in a regulated industry (pharmaceutical, biotech, medical devices)

• Solid understanding of Data Centric Submissions, including structured regulatory data standards such as:

• IDMP (Identification of Medicinal Products)
• ISO SPOR (Substances, Products, Organisations, Referentials)
• eCTD (electronic Common Technical Document)
• FHIR (Fast Healthcare Interoperability Resources) — desirable

• Familiarity with regulatory submission requirements from agencies including EMA, FDA, and/or MHRA

• Strong command of Agile methodologies (Scrum/Kanban); certified preferred (CSPO, SAFe PO/PM)

• Excellent ability to translate complex regulatory data requirements into actionable technical stories

• Experience working with data modelling, metadata standards, or clinical/regulatory data management platforms

Desirable Skills:

• Exposure to xEVMPD, XSLT, RDF/OWL ontologies, or DITA in a submissions context

• Familiarity with RIMS (Regulatory Information Management Systems) such as Veeva Vault, LORENZ, or similar

• Understanding of clinical data standards (CDISC, SDTM, ADaM)

• Background in regulatory affairs, medical writing, or data governance

Personal Attributes:

• Strategic thinker with strong attention to detail

• Confident communicator capable of engaging both technical and non-technical audiences

• Comfortable with ambiguity and able to drive clarity in fast-moving environments

• Collaborative and outcome-focused with a continuous improvement mindset

• Passionate about data quality and regulatory compliance