CMC Regulatory Content & Digital Enablement Lead

Merck & Co.; Rahway (NJ); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Hybrid work arrangement

401(k) plan and benefits

Job summary

Merck & Co. is seeking a Director of CMC Operations Content Management and Digital Enablement to lead global content strategy across the lifecycle, partnering with Regulatory Affairs, CMC, Quality, IT, and stakeholders.

This role focuses on governance, structured content, and digital tools to enable compliant, inspection-ready regulatory content processes. The ideal candidate combines deep regulatory content management expertise with leadership, change management, and analytics to modernize the

Qualifications

• Bachelor's degree required; advanced degree preferred in Life Sciences, Regulatory Affairs, Information Systems, or related field.
• Extensive experience in content management, regulatory operations, or pharmaceutical operations, with strong emphasis on CMC content processes.
• Demonstrated experience leading content management strategy, governance, or process improvement initiatives.
• Experience with digital transformation, system implementation, or content platform optimization.

Responsibilities

• Define and lead the CMC content management strategy across the content lifecycle.
• Establish governance, standards, and operating procedures for content creation, review, reuse, maintenance, archiving, and retrieval.
• Serve as the enterprise SME for content management processes supporting CMC regulatory activities.
• Drive consistent application of document standards, metadata, taxonomy, and version control practices.
• Ensure content management processes support compliance, inspection readiness, and global regulatory requirements.
• Identify and implement opportunities to improve content quality, consistency, and reuse across the organization.

Skills

Regulatory content management

Structured content & modular authoring

Metadata & taxonomy governance

Document lifecycle management

Cross-functional collaboration

Strategic leadership

Change management

Digital enablement

Regulatory submissions support

KPI & data analytics

Education

Bachelor's degree

Advanced degree preferred

Tools

Veeva Vault

Lorenz docuBridge

Microsoft Power BI

Job description

Merck & Co. is seeking a Director of CMC Operations Content Management and Digital Enablement to lead global content strategy across the lifecycle, partnering with Regulatory Affairs, CMC, Quality, IT, and stakeholders.

This role focuses on governance, structured content, and digital tools to enable compliant, inspection-ready regulatory content processes. The ideal candidate combines deep regulatory content management expertise with leadership, change management, and analytics to modernize the