Head of Structured Content & Regulatory Data (Hybrid)

CamWebDir; Greater London; Hybrid; GBP 140,000 - 180,000; Full time

Job summary

Merck & Co., Inc. in the UK seeks a Director of Structured Content Authoring to lead a transition to a data-driven, component-based regulatory information model.

You will define vision, governance, and an execution plan that links regulatory content, master data and enterprise data governance to deliver reusable, traceable assets. You will partner with Regulatory Affairs, Data Management, Labelling and Manufacturing to align stakeholders, drive IDMP governance, and shape future-state

Qualifications

• Significant life sciences regulatory data governance experience.
• Experience with IDMP, RIM platforms, master data management, information architecture and digital transformation.
• Knowledge of ISO IDMP, XEVMPD/Article 57 and EMA SPOR is highly desirable.
• Ability to establish governance frameworks, operating models and data standards for regulatory compliance and data quality.
• Strong strategic leadership and stakeholder management across cross-functional teams.

Responsibilities

• Establish governance structures, ownership models, decision rights, quality standards and stewardship across regulatory content and data domains.
• Oversee reusable content components and data assets covering labelling, CMC, clinical and submission content for reuse and traceability.
• Provide strategic leadership for IDMP governance and related data domains within global standards.
• Shape future-state architecture linking RIM platforms, structured content solutions, master data management and terminology services.
• Ensure automation, AI and regulatory tech are grounded in governed, traceable content and data.

Skills

Collaborative Leadership

Detail-Oriented

Operations Support

Process Improvements

Regulatory Compliance

Regulatory Experience

Regulatory Processes

Tools

Veeva Vault RIM

Structured Content Authoring

Data Catalogues

Knowledge Graphs

FHIR

Automation Technologies

RIM Platforms

Job description

Merck & Co., Inc. in the UK seeks a Director of Structured Content Authoring to lead a transition to a data-driven, component-based regulatory information model.

You will define vision, governance, and an execution plan that links regulatory content, master data and enterprise data governance to deliver reusable, traceable assets. You will partner with Regulatory Affairs, Data Management, Labelling and Manufacturing to align stakeholders, drive IDMP governance, and shape future-state