New · posted Oct 27
Merck · Pharmaceuticals
Reporting and Solutions - Senior Specialist, Regulatory Affairs
- Upper Gwynedd, PA +1 more
- Hybrid
- Full-time
- Senior & Principal
The role
The Submission Planning and Requirements Management (SPRM) team manages the submission planning capability for Global Regulatory Affairs and Clinical Sciences, supporting regulatory submission planning through robust, high‑quality planning data, reporting, and innovative solutions.
We are seeking a Senior Specialist to support data quality, reporting, and tool development across our submission planning ecosystem. This role will play a key part in developing Power Platform solutions, supporting reporting and analytics, and partnering with stakeholders to ensure high‑quality data for downstream consumers across GRACS.
What you need
Required Qualifications
- Bachelor’s degree.
- 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.
Required Skills
Dashboard Reporting, Data Analysis Tools, 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
Travel Requirements
No Travel Required
Preferred Qualificationsnice to have
- Experience in Regulatory Operations, including submission planning or related regulatory processes.
- Familiarity with data migration efforts and system transformations.
- Experience supporting tools and data sets used by downstream reporting consumers.
- Comfort working in an evolving digital landscape with a focus on continuous improvement and innovation.
What you'll do
- 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.
Pay and benefits
Merck didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Exciting work in a great team, global projects, international environment
Opportunity to learn and grow professionally within the company globally
Hybrid working model, flexible role pattern
Pension and health insurance contributions
Internal reward system plus referral program
5weeks
5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution
Cafeteria for tax free benefits according to your choice (meal vouchers, sport, culture, health, travel, etc.), Multisport Card
Vodafone, Raiffeisen Bank, Foodora, and other discount programs
Up-to-date laptop and iPhone
Parking in the garage for drivers or showers for bikers
Competitive salary, incentive pay, and many more
Where you'll work
Upper Gwynedd, PA +1 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Rahway, NJ
More jobs in Upper Gwynedd, PA +1 moreWorking conditions
Not Indicated
Hazardous Material(s)
NA
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Flexible Work Arrangements
Not Applicable
Job Posting End Date
11/21/2026
*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.
Equal opportunity, accessibility and legal noticesMerck's statements, word for word
Search Firm Representatives Please Read Carefully
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.
Job intelligence
The context around this role
Live data · October 28, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US5 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $122,000 | $123,500 | $123,500 |
Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, October 28, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Operations
The general path across 43 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Regulatory submissions6
- Documentation and SOPs3
- Validation and qualification2
- Quality systems and risk2
- Data and digital systems2
- GMP and compliance1
Company hiring pulse
Merck on Regulatory Jobs
- 17
- Open roles
- 17
- Distinct roles
- 7
- Locations
By discipline
- Regulatory12 71%
- Quality5 29%
By level
- Director9 53%
- Senior & Principal4 24%
- Associate & Specialist3 18%
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Reporting and Solutions - Senior Specialist, Regulatory Affairs at Merck
Applications close November 21.