Director, CMC Content Strategy & Digital Enablement

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

Benefits offered by this job

Annual bonus

Long-term incentive

Medical insurance

Dental and vision insurance

401(k) plan

Job summary

Merck seeks a Director of CMC Operations Content Management and Digital Enablement to lead global regulatory content, governance, and digital enablement for chemistry, manufacturing, and controls content across the lifecycle.

You will partner with Regulatory Affairs, CMC, Quality, IT, and stakeholders to define operating models, drive modernization, and enable AI-enabled, modular content practices for scalable, inspection-ready regulatory processes.

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, 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.
• Develop and maintain a scalable content management operating model aligned with business needs and regulatory expectations.
• Partner with cross-functional stakeholders to define roles, responsibilities, workflows, and governance forums.
• Lead process improvement initiatives that reduce duplication, improve efficiency, and strengthen control.
• Establish and monitor performance metrics related to content quality, cycle time, reuse, compliance, and operational effectiveness.
• Support audit and inspection readiness through strong content governance and data integrity practices.
• Lead the implementation, optimization, and adoption of digital tools that support content management capabilities.
• Partner with IT and business stakeholders to define business requirements, future-state workflows, and system enhancements.
• Evaluate and advance opportunities to leverage automation, AI, structured content, and digital technologies to improve content operations.
• Serve as a strategic business partner for content-related platform enhancements and digital capability roadmaps.
• Support adoption of content management systems, document management tools, and related regulatory platforms.

Skills

Regulatory content management

Structured content

Leadership

Change management

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree preferred

Tools

Veeva Vault

LOrenz docuBridge

Microsoft Power BI

Job description

Merck seeks a Director of CMC Operations Content Management and Digital Enablement to lead global regulatory content, governance, and digital enablement for chemistry, manufacturing, and controls content across the lifecycle.

You will partner with Regulatory Affairs, CMC, Quality, IT, and stakeholders to define operating models, drive modernization, and enable AI-enabled, modular content practices for scalable, inspection-ready regulatory processes.