Director, Structured Content & Regulatory Data Governance

MSD Malaysia; Greater London; Hybrid; GBP 150,000 - 210,000; Full time

Job summary

Merck Sharp & Dohme LLC (Merck & Co., Inc.), Rahway, NJ, USA, seeks a Director, Structured Content Authoring to lead the transformation from document-centric regulatory operations to a data-driven, component-based model. You will define vision, governance and an investment roadmap spanning content, master data and metadata management.

You will align stakeholders across Regulatory Affairs, Data Management, Labelling, CMC, Clinical, Safety, Quality, Manufacturing, Supply Chain and Technology to

Qualifications

• Extensive life sciences regulatory data governance experience.
• Knowledge of IDMP, RIM platforms and information architecture.
• Experience with global regulatory standards (ISO IDMP, XEVMPD/Article 57, EMA SPOR).
• Leadership in governance, ownership structures and data standards.

Responsibilities

• Establish governance structures, ownership models, decision rights and quality standards across regulatory content and data domains.
• Oversee reusable content components and data assets for lifecycle traceability.
• Lead IDMP governance including product and master data governance.
• Collaborate with Regulatory Technology, enterprise architecture and data engineering teams to shape future-state architecture.

Skills

Collaborative Leadership

Strategic Leadership

Executive communication

Stakeholder management

Regulatory Compliance

Regulatory Data Governance

Data governance

Tools

Veeva Vault RIM

Structured Content Authoring

Data catalogues

FHIR

Automation technologies

Job description

Merck Sharp & Dohme LLC (Merck & Co., Inc.), Rahway, NJ, USA, seeks a Director, Structured Content Authoring to lead the transformation from document-centric regulatory operations to a data-driven, component-based model. You will define vision, governance and an investment roadmap spanning content, master data and metadata management.

You will align stakeholders across Regulatory Affairs, Data Management, Labelling, CMC, Clinical, Safety, Quality, Manufacturing, Supply Chain and Technology to