Associate Director, Regulatory Affairs - Power Platform Solutions Specialist

Job Description

Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. We are building a new kind of healthcare company, one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill and teamwork of individuals who collaborate with mutual respect and shared accountability.

The Associate Director, Regulatory Affairs – Power Platform Solutions Specialist is a hands-on technical execution role supporting our system, the business-built country regulatory requirements management platform within Global Regulatory Affairs and Clinical Safety. Our system is built on Microsoft Power Platform, with Dataverse as its data foundation, Power Apps for user experiences, Power Automate for workflow and notifications, Power BI for analytics, Microsoft Teams for notifications, and SharePoint for support and governance content.

As a member of the Platform Team, the incumbent translates approved architecture and business designs into secure, reliable, supportable solutions. The role executes application configuration, data engineering, automated workflows, environment and pipeline management, defect remediation, technical testing, release deployment, and production support. The specialist takes direction from the System Platform Architect and Design Authority, and works alongside the System Operations Lead to validate success of development activities.,

Responsibilities

Application Build & Configuration

• Implement Power Apps user-interface changes in accordance with approved designs and established architecture standards.
• Configure and maintain Dataverse tables, columns, relationships, business rules, views, forms, security roles, permissions, and access-provisioning logic.
• Build, support, and optimize Power Automate flows, workflows, notifications, and other approved automation used by the system.
• Translate solution designs and business requirements into working, testable, and maintainable platform components.
• Identify opportunities to improve the current system, bring innovative enhancement ideas, remain versed in new and emerging Power Platform tools, design capabilities, and user-interface development approaches supporting modernized Power Apps UI and usability, efficiency, and long-term platform value.

Application Life Cycle Management, Pipelines & Environnements

• Manage solution movement and deployments across Development, Test/User Acceptance Test, and Production environments.
• Prepare and deploy approved upgrades, defect fixes, hotfixes, and enhancements while maintaining environment parity and configuration consistency.
• Perform pre-deployment and post-deployment verification, document deployment outcomes, and support controlled rollback or corrective action when required.
• Maintain solution versioning, deployment notes, release evidence, and technical traceability aligned with system Software Development Lifecycle expectations.

Data Engineering, Migration & Operational Scripts

• Develop, test, execute, and document scripts and repeatable processes for data cleanup, migration, correction, reconciliation, and bulk remediation.
• Perform field-level quality checks to confirm that transferred data is complete and accurate, not solely that record counts match.
• Support data fixes during business validation, User Acceptance Test, release, and hypercare windows, including approved non-architectural Production hotfixes.
• Partner with business data owners and technical leads to investigate discrepancies, protect the trusted data baseline, and prevent reuse of superseded or flawed source files.

Defect Resolution, Testing & Production Support

• Diagnose technical issues across Power Apps, Dataverse, Power Automate, Power BI dependencies, permissions, data, integrations, and environment configuration.
• Perform thorough unit testing of each developed fix in the Development environment before handoff for broader system testing.
• Provide technical notes, deployment details, and test evidence that clearly describe the defect, change made, expected behavior, and validation performed.
• Coordinate with the System Operations Lead and business requestors through system testing and user validation; address gaps, regressions, or incomplete resolution.
• Participate in release and hypercare coverage, issue triage, root-cause investigation, and escalation to Microsoft or Enterprise IT as appropriate.

Technical Documentation, Compliance & Engineering Quality

• Create and maintain accurate technical documentation, including configuration specifications, solution designs, data models, flow and workflow logic, deployment procedures, support runbooks, and known technical dependencies.
• Apply Power Platform engineering practices for maintainability, scalability, performance, security, reusable design, and controlled data exposure.
• Support peer review, code and solution review, auditability, backup and recovery readiness, and change-control evidence.

Cross-Functional Delivery & Continuous Improvement

• Work effectively in a matrixed, global environment with Regulatory Affairs, Chemistry, Manufacturing and Control, Regulatory Affairs International, RSI, System Process and Regulatory Innovation, Data Governance, Change Control Board representatives, and technical partners.
• Provide clear technical estimates, risks, dependencies, and implementation options to support release planning and prioritization.
• Support approved enhancements and interoperability opportunities involving system regulatory data, reporting, planning tools, and future AI-enabled solutions.
• Contribute to a sustainable business-supported operating model by transferring knowledge, documenting repeatable procedures, and enabling other support-team members.

Education

• Bachelor’s degree or equivalent in Computer Science, Information Systems, Data Engineering, Engineering, Regulatory Affairs, Life Sciences, or a related discipline.
• Advanced degree and/or relevant Microsoft Power Platform certifications are preferred.

Required Experience

• Minimum of five (5) years of relevant experience developing, configuring, deploying, or supporting enterprise business applications.
• Demonstrated hands-on experience with Microsoft Power Platform, including Power Apps, Dataverse, Power Automate, and solution/application lifecycle management.
• Experience designing or configuring Dataverse data models, relationships, business rules, security roles, permissions, views, forms, and environment-specific configuration.
• Experience managing Dev/Test/Production environments, deployment pipelines, managed solutions, release packages, and production change controls.
• Experience developing data migration, reconciliation, cleanup, or correction processes and validating data at record and field level.
• Experience troubleshooting complex application, workflow, permission, data, integration, and deployment issues through documented root-cause analysis.
• Experience performing technical/unit testing and preparing clear evidence for system testing and business validation.
• Experience creating and maintaining technical SDLC documentation, operational runbooks, configuration specifications, and deployment records.
• Ability to work effectively with a global audience, including cross-regional stakeholders, technical teams, and business partners across time zones and cultures.
• Strong collaboration, communication, organization, and prioritization skills, with the ability to manage overlapping releases, operational support, and enhancement work in a regulated matrix environment.

Preferred Experience

• Experience supporting pharmaceutical, biotechnology, regulatory, safety, clinical, or other regulated business processes.
• Experience with Power BI datasets and reports, Microsoft Teams notification patterns, SharePoint integration, APIs, connectors, or broader Microsoft 365 integration.
• Experience with Jira or comparable backlog, source-control, and technical work-management tools.
• Knowledge of Power Platform governance, security, performance optimization, delegation, solution checker, peer review, and enterprise support practices.
• Experience supporting global UAT, release readiness, post-production hypercare, and direct engagement with Microsoft support.
• Experience designing reusable automation or interoperability patterns and supporting AI-enabled or agent-based solutions using governed enterprise data.

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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:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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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. 

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