IT Project Manager Financial client
Jersey City, NJ21 days ago
- $65.01 Per Hour
- Contractor
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Skills
- Acceptance Testingunmatched
- Agile Programming Methodologiesunmatched
- Atlassian JIRAunmatched
- Biotech and Pharmaceuticalunmatched
- Bug Tracking/Defect Managementunmatched
- Business Analysisunmatched
- Change Controlunmatched
- Change Managementunmatched
- Data Qualityunmatched
- Documentationunmatched
- Establish Prioritiesunmatched
- FDA (Food and Drug Administration)unmatched
- GxPunmatched
- ICH Regulationsunmatched
- Leadershipunmatched
- Maintain Complianceunmatched
- Process Improvementunmatched
- Product Backlogunmatched
- Product Managementunmatched
- Quality Assuranceunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Regulatory Submissionsunmatched
- Requirements Managementunmatched
- Requirements Validation/Verificationunmatched
- Scrum Project Management and Software Developmentunmatched
- Sprint Planningunmatched
- Standup Meetingsunmatched
- System Validationunmatched
- Test Plan/Scheduleunmatched
- Test Scenariounmatched
- Thought Leadershipunmatched
- Time Managementunmatched
- Validation Testingunmatched
Description
- Act as Product Owner for global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements.
- Gather, analyze, and document business requirements from regulatory stakeholders across global regions, ensuring clarity and completeness.
- Comfortable to work with business users, PM, vendors and Sr. leadership
- Manage product backlogs in JIRA, defining clear user stories, acceptance criteria, and prioritization based on business value.
- Collaborate with development, QA, and regulatory teams to ensure product features meet both technical specifications and regulatory standards.
- Facilitate workshops, requirement-gathering sessions, and backlog grooming using Confluence for documentation and collaboration.
- Drive solution design discussions, ensuring integration with existing regulatory and submission management platforms.
- Oversee end-to-end delivery of regulatory systems enhancements, including planning, testing, validation, and deployment.
- Ensure adherence to pharmaceutical regulatory frameworks (e.g., FDA, EMA, ICH) and compliance with data integrity and GxP standards.
- Partner with IT, quality, and compliance teams to manage change control and validation activities for regulated systems.
- Provide thought leadership on digital tools and process optimization in the global regulatory affairs space.
Support User Acceptance Testing (UAT) by developing test scenarios, coordinating execution with business users, and validating results against requirements. - Track, triage, and resolve defects identified during UAT, working closely with developers and testers to ensure timely fixes.
- Participate in and lead daily Scrum stand-ups, sprint planning, reviews, and retrospectives to ensure team alignment and delivery velocity.
Numbers & Facts
| Location | Raritan, NJ |
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