Digital Innovation & Systems Senior Specialist

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.

- 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.

-  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.

-  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.

- Enhance operational excellence, ensure high-quality data, and drive innovation through collaborative ideation and the strategic adoption of new/enhanced technologies.

-  With guidance from manager, contribute to process improvements within various tools to increase efficiency and effectiveness.

- 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.

-  Mentor and coach RPP personnel impacted by tool or business process changes on the concepts, methods, and nuances of the changes.

-  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.

-  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.

- Represent Regulatory Planning and Publishing and the Project Management profession in forums outside the department and outside the company

Desired Experience & Skills:

- 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.

-  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.

-  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

- 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, Lítačka, 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:

Employee Training Programs, Global Communications, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/12/2026

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