Digital Innovation & Systems Senior Specialist

Merck & Co CZE - Central Bohemian - Prague (Five) Updated 24 September 2026
PharmaRegulatory AffairsQuality Assurancepythonregulatory submissionemacroraveinform

Job description

Job Description The Senior Specialist of Digital Innovation & Systems will be accountable for the oversight of various tools and systems utilized by the Regulatory Planning and Publishing (RPP) Team. This position will understand the enterprise-wide tools utilized by RPP and the implications of the GRACS Digital Strategy, including the new tools associated with the strategy, and its impact on Regulatory Submission Planning & Publishing as GRACS moves to creating a future state of working with data that are more connected and agile. The position will work closely with the DIS Associate Directors, Regulatory Innovation & Information Management (RIIM) and Information Technology (IT) on various projects. They will assist with ensuring the perspective of RPP is taken into consideration during tool development and/ or modifications. They will work towards ensuring there is an understanding of the cross-tool/ business process connections for all aspects of our digital capabilities as it impacts the RPP Team. This position will serve a key role to ensuring robust change management including communications and training is available to the RPP team as each aspect of the Digital Strategy is rolled out. Key Responsibilities: Project Management : Foundational understanding of planning, executing, and overseeing projects to achieve team-oriented goals, ensuring project requirements are met to the satisfaction of stakeholders and contributing to organizational success. v Understand the fundamentals of the existing enterprise-wide digital tools available to and/or utilized by the RPP Team, and recommend adoption of new digital tools supported by Microsoft, AI, and others for the RPP Team. v Understand the GRACS Digital Strategy and its impact on the RPP Team, including which existing tools will be modified or retired, and which new tools will be introduced. v Represent Regulatory Planning and Publishing and the Project Management profession in forums outside the department and outside the company. Problem Solving and Critical Thinking: Capable of analysing and evaluating systems and processes, adopting a proactive approach to challenges through effective problem-solving. v Enhance operational excellence, ensure high-quality data, and drive innovation through collaborative ideation and the strategic adoption of new/enhanced technologies. v With guidance from manager, contribute to process improvements within various tools to increase efficiency and effectiveness. v Raise any potential quality or compliance risks associated with the use of the various GRACS tools to the RPP Quality & Compliance Management Director and/or DIS Leadership. Facilitation : Foundational skills in leading discussions and decision-making processes to enhance collaboration and productivity within cross-functional teams, encouraging participation, managing conflicts, and structuring discussions to meet team objectives. v Mentor and coach RPP personnel impacted by tool or business process changes on the concepts, methods, and nuances of the changes. v May perform testing on various tools/systems and provide subsequent training to RPP. Communication Skills: Demonstrates the ability to communicate clearly and effectively, both verbally and in writing, across various organizational levels. v Raise any potential quality or compliance risks associated with the use of the various GRACS tools to the RPP Quality & Compliance Management Director and/or DIS Leadership. v Represent Regulatory Planning and Publishing and the Project Management profession in forums outside the department and outside the company. Education Minimum Requirement: High School diploma or equivalent plus 10 years of relevant experience Associate degree plus 8 years of relevant experience Bachelor’s degree plus 5 years relevant experience Desired Experience & Skills: - 5 years pharmaceutical experience with emphasis on business process and supporting technology preferably within a regulatory affairs function. - Experience with platforms and processes enabling regulatory submission planning, document management, publishing, and submission tracking. - Skilled at gathering stakeholder inputs and translating them into clear, actionable business requirements. - Working knowledge of solution platforms such as Microsoft Power Platform, SharePoint, and Generative AI, with proficiency in coding languages (e.g., Python) to deliver applications and data-driven reports/metrics. - Demonstrated ability to assess operations and pinpoint opportunities where technology solutions (e.g., automation, analytics, integrations) can drive measurable improvements. v Demonstrated situational leadership and creative problem solving within organizations and teams. - Strong interpersonal skills and experience in handling different cultures, with effective communication skills in English and regional languages. Ability to lead by influence and work effectively in matrix organizational structures. - Strong understanding of Application Lifecycle Management (ALM) and Software Development Lifecycle (SDLC) principles and best practices. - Expert in project management methodologies (e.g., PMP, Sigma, Change Management, etc.) and associated toolsets (e.g., MS Project for project planning, MS Excel for data analysis and reporting). - The incumbent may manage a team of direct reports and will be committed to investing in the growth, success, and well-being of this team. - Drive team performance: Help team set clear priorities aligned to Our Strategic Priorities and check in with them regularly to guide their work. - Create a feedback culture: Create a safe environment for giving and receiving impactful feedback to drive performance and growth. - Develop every team member: Partner with every member of team to identify development opportunities in line with their aspiration and the needs of the business. - May perform other duties as assigned. What we offer: Exciting work in a great team, global projects, international environment Opportunity to learn and grow professionally within the company globally Hybrid working model, flexible role pattern Pension and health insurance contributions Internal reward system plus referral program 5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution Cafeteria for tax free benefits according to your choice (meal vouchers, sport, culture, health, travel, etc.), Multisport Card Vodafone, Raiffeisen Bank, Foodora, and other discount programs Up-to-date laptop and iPhone Parking in the garage for drivers or showers for bikers Competitive salary, incentive pay, and many more Required Skills: Business Intelligence (

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