Digital Innovation & Systems Senior Specialist

Job DescriptionThe 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 applyCurrent Contingent Workers apply**Search 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:**Regular**Relocation:****VISA Sponsorship:****Travel Requirements:****Flexible Work Arrangements:**Hybrid**Shift:****Valid Driving License:****Hazardous Material(s):****Job Posting End Date:**04/12/2026**\*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.**#J-18808-Ljbffr