Director of CMC Regulatory Content & Digital Enablement

Merck & Co.; North Wales (Montgomery County); Hybrid; USD 173,000 - 273,000; Full time

Job summary

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

The role emphasizes structured authoring, metadata standards, and digital enablement to ensure compliant, scalable, and inspection-ready content processes. The ideal candidate combines regulatory content expertise with leadership and

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.
• Strong communication, influence, and stakeholder management skills.
• Demonstrated ability to work effectively across complex global and cross-functional environments.

Responsibilities

• Define and lead the CMC content management strategy across the content lifecycle.
• Establish governance, standards, and operating procedures for content creation, review, approval, 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.
• Champion structured authoring and modular content approaches to enable more efficient content operations and future digital capabilities.

Skills

Content management

Regulatory operations

Leadership

Stakeholder management

Change management

Digital enablement

Regulatory submissions

Education

Bachelor's degree

Advanced degree preferred in Life Sciences / Regulatory Affairs / Information Systems

Tools

Veeva Vault

Lorenz docuBridge

Microsoft Power BI

Job description

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

The role emphasizes structured authoring, metadata standards, and digital enablement to ensure compliant, scalable, and inspection-ready content processes. The ideal candidate combines regulatory content expertise with leadership and