Senior Director, Business Platform Strategy & Operations

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

Benefits offered by this job

Annual bonus

Long-term incentive

401(k) plan

Medical, dental, vision insurance

Job summary

Merck & Co. seeks a strategic leader to run Regulatory Platform Operations within RIIM, driving end-to-end system management, governance and value delivery.

You will lead a cross-functional team of employees, contractors, and vendors to optimize platforms, ensure regulatory compliance, and manage budgets and contracts. As part of the RIIM Leadership Team, you will shape platform roadmaps, enable data-driven decisions, and drive AI-enabled innovations while maintaining strong stakeholder

Qualifications

• 10+ years in regulatory operations
• 5+ years leading hybrid teams of employees, contractors and vendors
• Significant experience with Veeva RIM operations
• Experience implementing digital solutions in regulated environments
• Strong collaboration with IT, Finance, HR and vendors
• Ability to drive CAPAs/NCIR resolutions and audits

Responsibilities

• Oversee end-to-end regulatory platform operations and optimization
• Collaborate with RIIM BSOs, stakeholders, IT and vendors to shape roadmap
• Ensure governance, compliance, risk mitigation and KPIs
• Lead analytics, adoption insights and ROI measurement for platforms
• Manage budgets, vendor contracts and procurement
• Drive change communications and system adoption across regions

Skills

Regulatory affairs leadership

Strategic leadership

Cross-functional leadership

Veeva RIM operations

Digital strategy

Stakeholder collaboration

Education

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

Tools

Veeva RIM

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

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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 .

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

10/13/2026

*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:

R414438