Senior Specialist, Regulatory Affairs - Digital Support Solutions

1000 Merck Sharp & Dohme LLC; North Wales (Montgomery County); Vor Ort; USD 106.000 - 167.000; Vollzeit

Zusammenfassung

MSD is seeking a Sr. Specialist, Regulatory Affairs – Power Platform Solutions Specialist to provide hands-on support and configuration for the country regulatory requirements management platform.

You will configure Power Apps and Power Automate, maintain Dataverse data, and collaborate with users across regions to deliver approved improvements.

This role reports to the System Platform Architect within Global Regulatory Affairs, with emphasis on data quality, testing, and release readiness.

Qualifikationen

• Minimum of three years in business application support, configuration, development, or business analysis with hands-on Power Platform work.
• Experience configuring Power Apps and building or maintaining Power Automate flows.
• Working knowledge of Dataverse tables, columns, forms, views, and basic business rules, with 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.

Aufgaben

• Engage with users to clarify issues, gather requirements, and define acceptance criteria.
• Configure and update Power Apps forms, views, and UI components per approved requirements.
• Build and maintain Power Automate flows, approvals, and notifications.
• Coordinate releases and perform pre/post release checks with the technical team.
• Maintain ticket records, docs, and change logs for audit readiness.
• Collaborate with Regulatory Affairs and cross-functional partners across regions.

Kenntnisse

Power Platform

Dataverse

Power Apps

Power Automate

Power BI

SharePoint

Teams

Jira

Ausbildung

Bachelor's degree in Information Systems, Computer Science, Business, Engineering, Regulatory Affairs, Life Sciences

Tools

Power Platform

Dataverse

Power Apps

Power Automate

Power BI

SharePoint

Teams

Jira

Jobbeschreibung

Job Description Role Overview

The Sr. Specialist, Regulatory Affairs – Power Platform Solutions Specialist is a hands‑on application support and configuration role supporting our system, the business-built country regulatory requirements management platform within Global Regulatory Affairs and Clinical Safety. Our system 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 incumbent communicates directly with users who submit tickets to understand their 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 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.

Responsibilities

• User Engagement & Business Analysis Contact users who raise tickets to clarify the issue or request, understand their current process, and confirm the expected outcome and business impact. Gather relevant examples, screenshots, affected records, and steps to reproduce an issue; distinguish application defects, data concerns, access requests, and enhancement requests. Document clear requirements, simple process steps, and acceptance criteria; confirm understanding with the requestor and review proposed changes with the System Operations Lead and technical team. Keep requestors informed of progress, outstanding questions, and next steps, and coordinate follow‑up with the appropriate support or technical owner. Support user acceptance testing and confirm with requestors that the delivered change addresses the agreed need before recommending ticket closure.
• Application Build & Configuration 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, seeking technical review when needed. Suggest practical improvements to usability and routine workflows, and continue developing Power Platform skills.
• Application Maintenance & Release Support Assist technical leads with preparing approved application changes for Development, Test/UAT, and Production environments. Follow established release checklists and change‑control procedures for fixes and enhancements. Perform assigned pre‑release and post‑release checks and report unexpected results to the technical lead. Maintain release notes, test results, and change records; support deployment activities under technical supervision.
• Data Quality & Maintenance Support Support routine data imports, cleanup, and approved corrections using established tools, templates, and procedures. Compare source and system records and perform field‑level checks to identify missing or inaccurate information. Document data issues and work with requestors, business data owners, and technical leads to confirm appropriate corrections. Use approved source files and escalate complex migration, bulk‑update, or scripting needs to technical specialists.
• Defect Resolution, Testing & Production Support Investigate and reproduce routine Power Apps, Power Automate, data, and access issues; elevate complex issues with clear supporting details. Test application changes in Development before handoff for broader testing, including expected outcomes and common error scenarios. Document the issue, change made, expected behavior, and test results in the relevant ticket or change record. Coordinate with the System Operations Lead and requestors during user validation and follow up on unresolved issues or regressions. Participate in release support and post‑release monitoring, routing unresolved technical problems to the appropriate technical lead.
• Documentation, Compliance & Quality Maintain user requirements, configuration notes, workflow descriptions, support procedures, and user guidance. Follow established Power Platform standards, security procedures, and change controls when configuring or supporting applications. Participate in peer review and maintain complete ticket, testing, and change documentation to support traceability and audit readiness.
• Cross‑Functional Delivery & Continuous Improvement Collaborate with Regulatory Affairs business users, the System Operations Lead, and technical partners in a global, matrixed environment. Provide clear status updates, identify dependencies or blockers, and contribute task estimates to support prioritization. Identify recurring user questions and ticket trends and suggest practical application, process, or training improvements. Share knowledge and document repeatable procedures to help other support‑team members respond consistently.

Education

Bachelor’s degree or equivalent in Information Systems, Computer Science, Business, Engineering, Regulatory Affairs, Life Sciences, or a related discipline. Relevant Microsoft Power Platform training or certification is preferred; an advanced degree is not required.

Required Experience

• Minimum of three (3) 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, with the ability to balance assigned support tickets and enhancement tasks.

Preferred Experience

• 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.

EligibleforERP Required Skills

• Application Configuration
• Business Requirements Documentation (BRD)
• Data Quality Management
• End User Communication
• Microsoft Dataverse
• Microsoft Power Platform
• Technical Troubleshooting
• Ticket Management
• User Acceptance Testing (UAT)

Preferred Skills

• Change Controls
• Microsoft Power BI
• Microsoft Power Platform
• Microsoft SharePoint
• Microsoft Teams
• Process Mapping

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts.

Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $106,200.00 - $167,200.00 This range reflects the Company’s reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information: San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s):

Job Posting End Date: 11/18/2026 *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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.