Senior Director, Business Platform Strategy & Operations

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

Job summary

Merck seeks an experienced Regulatory Platform Operations leader to drive end-to-end sub-unit management within RIIM. You will collaborate with BSOs, IT, and vendors to shape roadmaps, ensure compliance, and optimize platform performance.

The role requires 10+ years in regulatory operations and 5+ years of leading hybrid teams, with experience in Veeva RIM and regulated digital solutions. Hybrid work model with travel up to 25% is offered.

Qualifications

• 10+ years in Regulatory operations
• 5+ years leading teams with hybrid workforce
• Experience with Veeva RIM operations
• Experience implementing digital solutions in regulated environments

Responsibilities

• Oversee end-to-end operations and management of a sub-unit within RIIM
• Drive platform lifecycle management, releases, enhancements, and cross-system coordination
• Maintain governance frameworks for consistency, compliance, and performance
• Shape platform roadmap with RIIM BSOs, stakeholders, IT and vendors
• Ensure platforms scaled for usability, regulatory compliance, and data alignment
• Lead systems adoption analytics, KPIs, and ROI measurement
• Provide cross-cutting BSO for RIIM tools like IPV Dashboard and Veeva AI solutions
• Translate GRACS Digital Strategy into executable plans
• Support system communications, release readiness, and change enablement

Skills

Executive Presence

Strategic Planning

Stakeholder Management

Governance Framework

People Leadership

Regulatory Affairs Management

Education

BA/BS in Scientific, Business Operations, or IT; MS or equivalent

Tools

Veeva

Job description

Job Description

Reporting to the Regulatory Innovation & Information Management (RIIM) Department Lead, this strategic leadership position oversees the end-to-end operations and management of an assigned sub-unit. As an active member of the RIIM Leadership Team, the role collaborates closely with department leadership to define, execute, and govern a harmonized Regulatory digital strategy. The incumbent leads a cross-functional workforce of internal employees, contractors, and external vendors to drive day-to-day business systems, operational processes, and innovative capabilities while ensuring strict regulatory compliance, quality governance, and proactive risk mitigation. Additionally, this leader maintains full operational accountability for subunit financial management—including vendor contracts, purchase orders, and budget administration—as well as talent acquisition and workforce planning.

Responsibilities

Regulatory Platform Operations & Optimization

• Act as a horizontal platform integrator across RIIM business systems, driving consistency and interoperability
• Drive platform lifecycle management, including releases, enhancements, and cross-system coordination
• Maintain governance frameworks to ensure consistency, compliance, and performance
• Partner with RIIM Business System Owners (BSOs), business stakeholders, IT and external vendors (e.g., Veeva) to shape platform roadmap, AI capabilities, and innovation priorities
• Ensure platforms are optimized for scalability, usability, and regulatory compliance
• Ensure integration and alignment across systems, data, and processes
• Accountable for Regulatory systems Business Continuity Plans (BCP), including annual readiness, scenario planning, and incident coordination
• Lead a centralized capability for systems adoption, user analytics, and insights generation
• Define and monitor KPIs for systems usage, adoption, and value delivery
• Use analytics to: Identify adoption gaps and drive targeted interventions, Quantify ROI from digital initiatives, Inform prioritization of enhancements and investments
• Enable data-driven continuous improvement, leveraging automation and AI where applicable
• As applicable provide Business System Ownership (BSO) for cross-cutting RIIM tools and capabilities (e.g., IPV Dashboard, Veeva AI solutions)

GRACS Digital Strategy Execution & System Communications

• Help translate GRACS Digital Strategy into execution
• Lead coordinated system communications, release readiness, and change enablement
• Ensure consistent stakeholder engagement and alignment across functions and regions
• Help drive a cohesive, user experience across regulatory platforms

GRACS Process- System Integration

• Ensure system capabilities and constraints support the designed process
• Support the Global Process Owner model

Education

• BA or BS in Scientific, Business Operations, or Information Technology related degrees; minimum MS or equivalent

Required Experience And Skills

• 10+ years working within a Regulatory operations role
• 5+ years of leading teams and a hybrid organization of employees, contractors, and vendors.
• Significant experience in Veeva RIM operations
• Experience with innovation strategy, implementation, and operations of digital solutions in a regulated environment
• Expertise in regulatory capabilities, operations, and business processes
• Strong experience in working closely with Functional Business area users, IT, Finance, HR, and vendors
• Ability to drive Corrective Action and Preventive Actions (CAPAs)/Non-Compliance Investigation Report (NCIRs) resolutions, Partner audits and Health Authority Inspections
• Ability to represent the organization at internal and external forums on RIM related topics
• Executive presence (writing and oral presentation)
• Demonstrated collaborative skills and ability to work in cross-functional and international environments
• Solid knowledge of regulatory processes, with a technology-process optimization mindset
• Demonstrated ability to recruit, train, and develop staff, to motivate others and drive continuous improvement
• Flexibility to operate in a matrix-managed environment and to support staff in that same environment
• Strategic Execution – Translates strategy into scalable, measurable outcomes
• Operational Excellence – Ensures disciplined, efficient, and compliant system operations
• Value Realization – Demonstrates measurable impact from technology investments
• Drives Transformation – Leads large-scale change through digital, data, and innovation

Required Skills

Business Alignment, Business Process Design, Contingency Plan, Decision Making, Executive Presence, Governance Framework, Interpersonal Relationships, Investments Analysis, Legal Compliance, Negotiation, People Leadership, Project Appraisals, Project Development, Project Planning, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Processes, Stakeholder Engagement, Stakeholder Management, Strategic Planning, Strategic Thinking, Strategy Deployment

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Employee Status

Employee Status Regular

Relocation

Relocation No relocation

VISA Sponsorship

VISA Sponsorship No

Travel Requirements

Travel Requirements 25%

Flexible Work Arrangements

Flexible Work Arrangements Hybrid

Shift

Shift Not Indicated

Valid Driving License

Valid Driving License No

Hazardous Material(s)

Hazardous Material(s) n/a

Job Posting End Date 10/13/2026

Requisition ID R414438

The salary range for this role is $173,200.00 - $272,600.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.