Senior Director, Business Platform Strategy & Operations

Job DescriptionReporting 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 & OptimizationAct as a horizontal platform integrator across RIIM business systems, driving consistency and interoperabilityDrive platform lifecycle management, including releases, enhancements, and cross-system coordinationMaintain governance frameworks to ensure consistency, compliance, and performancePartner with RIIM Business System Owners (BSOs), business stakeholders, IT and external vendors (e.g., Veeva) to shape platform roadmap, AI capabilities, and innovation prioritiesEnsure platforms are optimized for scalability, usability, and regulatory complianceEnsure integration and alignment across systems, data, and processesAccountable for Regulatory systems Business Continuity Plans (BCP), including annual readiness, scenario planning, and incident coordinationLead a centralized capability for systems adoption, user analytics, and insights generationDefine and monitor KPIs for systems usage, adoption, and value deliveryUse analytics to: Identify adoption gaps and drive targeted interventions, Quantify ROI from digital initiatives, Inform prioritization of enhancements and investmentsEnable data-driven continuous improvement, leveraging automation and AI where applicableAs 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 CommunicationsHelp translate GRACS Digital Strategy into executionLead coordinated system communications, release readiness, and change enablementEnsure consistent stakeholder engagement and alignment across functions and regionsHelp drive a cohesive, user experience across regulatory platformsGRACS Process–System IntegrationEnsure system capabilities and constraints support the designed processSupport the Global Process Owner modelEducation:BA or BS in Scientific, Business Operations, or Information Technology related degrees; minimum MS or equivalentRequired Experience and Skills:10+ years working within a Regulatory operations role5+ years of leading teams and a hybrid organization of employees, contractors, and vendors.Significant experience in Veeva RIM operationsExperience with innovation strategy, implementation, and operations of digital solutions in a regulated environmentExpertise in regulatory capabilities, operations, and business processesStrong experience in working closely with Functional Business area users, IT, Finance, HR, and vendorsAbility to drive Corrective Action and Preventive Actions (CAPAs)/Non-Compliance Investigation Report (NCIRs) resolutions, Partner audits and Health Authority InspectionsAbility to represent the organization at internal and external forums on RIM related topicsExecutive presence (writing and oral presentation)Demonstrated collaborative skills and ability to work in cross-functional and international environmentsSolid knowledge of regulatory processes, with a technology-process optimization mindsetDemonstrated ability to recruit, train, and develop staff, to motivate others and drive continuous improvementFlexibility to operate in a matrix-managed environment and to support staff in that same environmentStrategic Execution – Translates strategy into scalable, measurable outcomesOperational Excellence – Ensures disciplined, efficient, and compliant system operationsValue Realization – Demonstrates measurable impact from technology investmentsDrives Transformation – Leads large-scale change through digital, data, and innovationRequired 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 DeploymentPreferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS 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:EEOC Know Your RightsEEOC GINA Supplement​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 ActsThe salary range for this role is$173,200.00 - $272,600.00This 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 .You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). 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 OrdinanceLos 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 OrdinanceSearch 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: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:25%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aJob 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. SummaryLocation: USA - Pennsylvania - North Wales (Upper Gwynedd); USA - New Jersey - RahwayType: Full time