Senior Director, Regulatory Platform Strategy & Ops

Merck & Co.; North Wales (Montgomery County); Híbrido; USD 173 000 - 273 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual bonus

401(k) plan

Medical/dental/vision

Paid holidays & vacation

Hybrid work arrangement

Resumo da oferta

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.

Qualificações

• 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

Responsabilidades

• 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

Conhecimentos

Regulatory operations

Leadership

Veeva RIM

Regulatory digital strategy

Cross-functional collaboration

Data analytics

CAPA/NCIR resolutions

Executive presence

Formação académica

MS or equivalent

BA or BS in Scientific/Business/IT

Ferramentas

Veeva

RIIM systems

Descrição da oferta de emprego

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.