Senior Specialist, Regulatory Affairs - Digital Support Solutions

Merck•North Wales, PA

8d•$106,200 - $167,200•Hybrid

About The Position

The Senior Specialist, Regulatory Affairs – Digital Support Solutions is a hands-on application support and configuration role supporting a business-built country regulatory requirements management platform within Global Regulatory Affairs and Clinical Safety. The platform uses Microsoft Power Platform, including Dataverse, Power Apps, Power Automate, and Power BI, with Microsoft Teams and SharePoint supporting communications and support activities. As a member of the Platform Team, the specialist works directly with users who submit tickets to clarify issues and requests, documents basic business requirements, and helps deliver approved application improvements. The role configures Power Apps and Power Automate, investigates routine issues, supports data checks and testing, and maintains support documentation. The specialist works under the technical guidance of the System Platform Architect and Design Authority, coordinating priorities, user follow-up, and validation with the System Operations Lead. Complex architecture, integrations, security design, and deployment decisions remain with the appropriate technical leads.

Requirements

Bachelor’s degree or equivalent in Information Systems, Computer Science, Business, Engineering, Regulatory Affairs, Life Sciences, or a related discipline.
At least three years of relevant experience in business application support, configuration, development, or business analysis, including hands-on Power Platform work.
Practical experience configuring Power Apps and building or maintaining Power Automate flows.
Working knowledge of Dataverse tables, columns, forms, views, and basic business rules, with an understanding of access controls.
Experience speaking with users to clarify support tickets or requests and documenting business needs, expected outcomes, and acceptance criteria.
Ability to reproduce routine application issues, gather supporting information, and recognize when technical escalation is needed.
Experience checking data accuracy and supporting routine data maintenance using established procedures.
Experience testing application changes, recording results, and supporting user acceptance testing.
Ability to maintain clear ticket records, configuration notes, and user or support documentation and follow established change controls.
Ability to communicate effectively with business users and technical colleagues across regions and time zones.
Strong organization, problem-solving, and follow-through skills, including the ability to balance assigned support tickets and enhancement tasks.

Nice To Haves

Relevant Microsoft Power Platform training or certification.
Experience supporting pharmaceutical, biotechnology, regulatory, safety, clinical, or other regulated business processes.
Familiarity with Power BI reports, SharePoint lists, Microsoft Teams, and standard Microsoft 365 connectors.
Experience using Jira or comparable ticket and backlog tracking tools.
Basic familiarity with Power Platform solutions, Development/Test/Production environments, and controlled release procedures.
Experience supporting UAT, preparing simple process documentation, or providing user guidance and training.
Interest in expanding Power Platform skills and improving business processes through low-code solutions.

Responsibilities

Contact users who raise tickets to clarify issues or requests, understand their current processes, and confirm expected outcomes and business impact.
Gather examples, screenshots, affected records, and reproduction steps; distinguish application defects, data concerns, access requests, and enhancement requests.
Document requirements, process steps, and acceptance criteria; confirm understanding with requestors and review proposed changes with the System Operations Lead and technical team.
Keep requestors informed of progress and coordinate follow-up with the appropriate support or technical owner.
Support user acceptance testing and confirm that delivered changes address agreed needs before recommending ticket closure.
Configure and update Power Apps forms, views, and user-interface components using approved requirements and established patterns.
Maintain Dataverse tables, columns, views, and basic business rules under technical guidance; support access requests using approved procedures.
Build and maintain routine Power Automate flows, approvals, and notifications using standard connectors and established designs.
Translate agreed requirements into straightforward application changes, seeking technical review when needed, and suggest practical usability and workflow improvements.
Assist technical leads in preparing approved changes for Development, Test/UAT, and Production environments.
Follow release checklists and change-control procedures; perform assigned pre-release and post-release checks and report unexpected results.
Maintain release notes, test results, and change records; support deployment activities under technical supervision.
Support routine data imports, cleanup, and approved corrections; compare source and system records and check fields for missing or inaccurate information.
Document data issues and coordinate appropriate corrections with requestors, business data owners, and technical leads; escalate complex migration, bulk-update, or scripting needs.
Investigate and reproduce routine Power Apps, Power Automate, data, and access issues, escalating complex issues with supporting details.
Test application changes in Development, including expected outcomes and common error scenarios; document issues, changes, expected behavior, and test results.
Coordinate user validation and follow up on unresolved issues or regressions; participate in release support and post-release monitoring.
Maintain requirements, configuration notes, workflow descriptions, support procedures, and user guidance; follow Power Platform standards, security procedures, and change controls.
Participate in peer review and maintain complete ticket, testing, and change documentation for traceability and audit readiness.
Collaborate with Regulatory Affairs business users, the System Operations Lead, and technical partners in a global, matrixed environment.
Provide status updates, identify dependencies or blockers, and contribute task estimates to support prioritization.
Identify recurring user questions and ticket trends, suggest application, process, or training improvements, and share repeatable procedures with support-team members.