Business System Associate Director - Labeling Operations

About the role

Merck is seeking a full-time Business System Associate Director for the Labeling Operations area within its GRACS Regulatory Innovation & Information Management organization. The role leads business analysts and system initiatives, acts as a bridge between global labeling business users and IT partners, and oversees system releases and support.

Key responsibilities

• Manage and lead Business Analysts for complex data analytics applications.
• Lead system development, maintenance, enhancement and monitoring initiatives.
• Act as liaison between global labeling business users and IT partners to define business requirements.
• Facilitate system operations meetings, resolving issues and managing competing priorities through proper escalation.
• Develop user-facing system resources in line with the current system version, working with Global Labeling, System Support, IT and Learning & Development.
• Lead system releases with IT business partners, covering requirements gathering, documentation, testing, implementation, deployment and hypercare.
• Oversee the system support model: monitor support cases, ensure thorough root cause investigations, detailed CAPAs and effective closure, and identify improvements to reduce compliance risk.
• Conduct system administrator activities and facilitate global user group forums, release communications and program updates.

Required profile

• BS/BA in science, engineering, IT or a related discipline.
• Functional working experience in system development/management in GxP-regulated areas preferred.
• 10+ years of experience in pharmaceutical regulatory affairs operations with labeling process and digital enablement experience strongly preferred.
• Experience with audit/inspection support for GxP systems and ability to explain complex concepts under pressure.
• Strong leadership, problem-solving, communication and organizational skills, with attention to detail.

Required skills

• GxP (GMP) requirements and GxP validation
• Labeling systems and labeling compliance
• Software Development Life Cycle (SDLC) and system management
• Authoring technical guidance, user guidance and SOPs, and change control management
• Business process mapping and system design for workflow management (an asset)

What we offer

• Hybrid working model and flexible role pattern
• Pension and Canadian medical insurance contributions
• 5 weeks annual leave, 5 sick days, 15 days of certified sick leave, 40 paid volunteer hours and 12 weeks of parental contribution
• Tax-free cafeteria benefits, multisport card, Vodafone, Raiffeisen Bank and Foodora discounts
• Up-to-date laptop and iPhone, parking, showers and refreshments
• Competitive salary, incentive pay and professional growth opportunities