Senior Regulatory Data & Reporting Specialist

Merck; Upper Gwynedd Township (Montgomery County); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work model

Pension and health insurance

5 weeks annual leave

Laptop and iPhone

Job summary

Merck is seeking a Senior Specialist in Submission Planning & Requirements Management to support data quality, reporting, and tool development across the SPRM ecosystem. The role emphasizes building Power Platform solutions and Power BI dashboards to enable robust planning, forecasting, and analytics for regulatory submissions.

You will partner with submission planners and cross‑functional teams, drive data quality initiatives, and translate stakeholder requirements into scalable data and

Qualifications

• Bachelor’s degree required.
• Hands‑on experience with the Microsoft Power Platform, ideally including Power Apps development.
• Experience developing reports and dashboards in Power BI.
• Strong data analysis skills.
• Experience supporting stakeholder engagement, including requirements gathering and issue troubleshooting.
• Ability to work across teams in a regulated, matrixed environment.

Responsibilities

• Support data quality management and reporting, including identification, analysis, and resolution of data quality issues.
• Develop and maintain Power Platform solutions (Power Apps, Power Automate, Dataverse) to support submission planning, forecasting, and demand management.
• Build and maintain Power BI reports and dashboards, providing actionable insights to planners, leadership, and downstream data consumers.
• Extract and prepare datasets in support of analysis, reporting, and data quality initiatives.
• Support data migration activities, including validation, reconciliation, and stakeholder issue resolution.
• Launch and manage data quality initiatives, engaging SME stakeholders for review, validation, and continuous improvement.
• Troubleshoot and resolve issues related to existing tools and datasets, working closely with key stakeholders.
• Partner with submission planners and cross‑functional teams to understand requirements and translate them into scalable data and reporting solutions.

Skills

Dashboard reporting

Data analysis

Data extraction

Data management

Data quality assurance

Data quality control

Data reconciliation

Data reporting

Detail‑Oriented

Drug Regulatory Affairs

Pharmaceutical Regulatory Affairs

Project Management

Quality Reporting

Regulatory Affairs Management

Regulatory Compliance

Regulatory Documents

Regulatory Operations

Regulatory Processes

Regulatory Strategy Development

Regulatory Submissions

Reporting Tools

Education

Bachelor’s degree

Tools

Power Platform (Power Apps/Power Automate)

Dataverse

Power BI

Job description

Merck is seeking a Senior Specialist in Submission Planning & Requirements Management to support data quality, reporting, and tool development across the SPRM ecosystem. The role emphasizes building Power Platform solutions and Power BI dashboards to enable robust planning, forecasting, and analytics for regulatory submissions.

You will partner with submission planners and cross‑functional teams, drive data quality initiatives, and translate stakeholder requirements into scalable data and