Senior Director, Business Platform Strategy & Operations

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

Benefits offered by this job

Annual bonus

401(k) plan

Medical/dental/vision

Paid holidays & vacation

Hybrid work arrangement

Job summary

Merck & Co. is seeking an experienced leader to oversee Regulatory Platform Operations within the RIIM domain.

You will manage end-to-end subunit operations, drive a harmonized digital strategy, and lead a cross-functional team of employees, contractors, and vendors to ensure regulatory compliance, quality governance, and cost control. The role emphasizes platform governance, adoption analytics, and ROI, with responsibility for BCP and talent planning in a matrix environment.

Qualifications

• 10+ years in a Regulatory operations role
• 5+ years of leading teams in a hybrid workforce
• Significant experience in Veeva RIM operations
• Experience with innovation strategy and digital solutions in regulated environments
• Expertise in regulatory operations and processes
• Strong collaboration with IT, Finance, HR, vendors
• Ability to drive CAPA/NCIR resolutions and audits
• Executive presence in writing and presentations
• Experience recruiting, training and developing staff
• Ability to operate in a matrix organization and drive transformation

Responsibilities

• Act as a platform integrator across RIIM business systems
• Drive platform lifecycle management and cross-system coordination
• Maintain governance frameworks for compliance and performance
• Shape platform roadmap with BSOs, stakeholders, IT and vendors
• Ensure scalability, usability and regulatory compliance
• Coordinate system data and process alignment
• Oversee regulatory systems business continuity planning
• Lead analytics and insights generation for adoption and ROI
• Define KPIs for system usage and value delivery
• Enable data-driven continuous improvement with automation and AI
• Possess BSO for RIIM tools like IPV Dashboard and Veeva AI solutions
• Translate GRACS digital strategy into executable plans
• Lead system communications, release readiness and change enablement
• Support Global Process Owner model and regulatory process-system integration

Skills

Regulatory operations

Leadership

Veeva RIM

Regulatory digital strategy

Cross-functional collaboration

Data analytics

CAPA/NCIR resolutions

Executive presence

Education

MS or equivalent

BA or BS in Scientific/Business/IT

Tools

Veeva

RIIM systems

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.

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

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 .

The application deadline for this position is stated on this posting.

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.

Search Firm Representatives Please Read Carefully-

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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