Regulatory Affairs Digital Innovation & Systems

<p style="text-align:left">Job Description</p><p style="text-align:inherit"></p><p>The Senior Specialist<span style="color:#808080"> </span>of Digital Innovation &amp; 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 &amp; Publishing as GRACS moves to creating a future state of working with data that are more connected and agile.</p><p></p><p> </p><p>The position will work closely with the DIS Associate Directors, Regulatory Innovation &amp; 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.</p><p> </p><p><b><u>Key Responsibilities:</u></b></p><p> </p><p><span></span></p><p><u>Project Management</u>: 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.</p><p>- 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.</p><p>-  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.</p><p>-  Represent Regulatory Planning and Publishing and the Project Management profession in forums outside the department and outside the company.</p><p> </p><p><u>Problem Solving and Critical Thinking:</u> Capable of analysing and evaluating systems and processes, adopting a proactive approach to challenges through effective problem-solving.</p><p>- Enhance operational excellence, ensure high-quality data, and drive innovation through collaborative ideation and the strategic adoption of new/enhanced technologies.</p><p>-  With guidance from manager, contribute to process improvements within various tools to increase efficiency and effectiveness.</p><p>- Raise any potential quality or compliance risks associated with the use of the various GRACS tools to the RPP Quality &amp; Compliance Management Director and/or DIS Leadership.</p><p> </p><p><u>Facilitation</u>: 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.</p><p>-  Mentor and coach RPP personnel impacted by tool or business process changes on the concepts, methods, and nuances of the changes.</p><p>-  May perform testing on various tools/systems and provide subsequent training to RPP.</p><p> </p><p><u>Communication Skills:</u> Demonstrates the ability to communicate clearly and effectively, both verbally and in writing, across various organizational levels.</p><p>-  Raise any potential quality or compliance risks associated with the use of the various GRACS tools to the RPP Quality &amp; Compliance Management Director and/or DIS Leadership.</p><p>- Represent Regulatory Planning and Publishing and the Project Management profession in forums outside the department and outside the company</p><p></p><p><b><u>Education Minimum Requirement:</u></b></p><p></p><p>- High School diploma or equivalent plus 10 years of relevant experience</p><p>-  Associate degree plus 8 years of relevant experience</p><p>-  Bachelor’s degree plus 5 years relevant experience</p><p></p><h1><b><u>Desired Experience &amp; Skills:</u></b></h1><p><span style="color:#000000">-  5 years pharmaceutical experience with emphasis on business process and supporting technology preferably within a regulatory affairs function.</span></p><p><span style="color:#000000">-  Experience with platforms and processes enabling regulatory submission planning, document management, publishing, and submission tracking.</span></p><p><span style="color:#000000">-  Skilled at gathering stakeholder inputs and translating them into clear, actionable business requirements.</span></p><p><span style="color:#000000">-  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.</span></p><p><span style="color:#000000">-  Demonstrated ability to assess operations and pinpoint opportunities where technology solutions (e.g., automation, analytics, integrations) can drive measurable improvements.</span></p><p><span style="color:#000000">-  Demonstrated situational leadership and creative problem solving within organizations and teams.</span></p><p><span style="color:#000000">-  Strong interpersonal skills and experience in handling diverse cultures, with effective communication skills in English and regional languages. Ability to lead by influence and work effectively in matrix organizational structures.</span></p><p><span style="color:#000000">-  Strong understanding of Application Lifecycle Management (ALM) and Software Development Lifecycle (SDLC) principles and best practices.</span></p><p><span style="color:#000000">-  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).</span></p><p><span style="color:#000000">-  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.</span></p><p><span style="color:#000000">-  Drive team performance: Help team set clear priorities aligned to Our Strategic Priorities and check in with them regularly to guide their work.</span></p><p><span style="color:#000000">-  Create a feedback culture: Create a safe environment for giving and receiving impactful feedback to drive performance and growth.</span></p><p><span style="color:#000000">-  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.</span></p><p><span style="color:#000000">- May perform other duties as assigned</span></p><p></p><p></p><p><b>Required Skills: </b></p>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<p></p><p><b>Preferred Skills: </b></p><p style="text-align:inherit"></p><p style="text-align:left">Current Employees apply <a target="_blank" href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld">HERE</a></p><p style="text-align:inherit"></p><p style="text-align:left">Current Contingent Workers apply <a target="_blank" href="https://wd5.myworkday.com/msd/d/task/1422$4020.htmld">HERE</a></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Search Firm Representatives Please Read Carefully </b><br />Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; 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. </p><p style="text-align:inherit"></p><p style="text-align:left"><b>Employee Status: </b></p>Regular<p style="text-align:inherit"></p><p style="text-align:left"><b>Relocation:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>VISA Sponsorship:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span>Travel Requirements:</span></b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Flexible Work Arrangements:</b></p>Hybrid<p style="text-align:inherit"></p><p style="text-align:left"><b>Shift:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Valid Driving License:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Hazardous Material(s):</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Posting End Date:</b></p>04/4/2026<p style="text-align:left"><b><span>*A job posting is effective until 11:59:59PM on the day <u>BEFORE</u> the listed job posting end date. Please ensure you apply to a job posting no later than the day <u>BEFORE</u> the job posting end date. </span></b></p>