Senior Specialist, Regulatory Affairs - Digital Support Solutions

MSD•Rahway, PA

8d•Hybrid

About The Position

The Senior Specialist, Regulatory Affairs – Digital Support Solutions is a hands-on application support and configuration role for a business-built country regulatory requirements management platform used 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, document basic business requirements, and help 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 and coordinates 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. The position collaborates with Regulatory Affairs business users and technical partners in a global, matrixed environment. The role requires a bachelor’s degree or equivalent in a relevant discipline and at least three years of relevant experience, including hands-on Power Platform work. The primary location is North Wales (Upper Gwynedd), Pennsylvania, and the work arrangement is hybrid. The posted base salary range for this primary location is $106,200–$167,200. The successful candidate is eligible for an annual bonus and long-term incentive, if applicable. The company offers medical, dental, vision, other insurance, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days.

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 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, with 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 and requests, understand their 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 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 user requirements into straightforward application changes and seek technical review when needed.
Suggest usability and workflow improvements and continue developing Power Platform skills.
Assist technical leads with preparing approved application changes for Development, Test/UAT, and Production environments.
Follow release checklists and change-control procedures for fixes and enhancements; perform assigned pre-release and post-release checks and report unexpected results.
Maintain release notes, test results, and change records, and support deployment activities under technical supervision.
Support routine data imports, cleanup, and approved corrections; compare source and system records and perform field-level checks for missing or inaccurate information.
Document data issues and work with requestors, business data owners, and technical leads to confirm appropriate corrections; 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 with the System Operations Lead and requestors during user validation, follow up on unresolved issues or regressions, and participate in release support and post-release monitoring.
Maintain user 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 ticket, testing, and change documentation for traceability and audit readiness.
Collaborate with business users, the System Operations Lead, and technical partners; provide status updates, identify dependencies or blockers, and contribute task estimates.
Identify recurring user questions and ticket trends, suggest application, process, or training improvements, and share repeatable procedures with support-team members.