Regulatory Affairs Digital Innovation & Systems

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

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.

-  Demonstrated situational leadership and creative problem solving within organizations and teams.

-  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.

-  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

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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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:

04/4/2026

*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.