What are the responsibilities and job description for the Technical Product Owner position at Cosmic-I LLC DBA Northern Base?
Serve as the Product Owner for global regulatory systems and solutions, ensuring product strategy and delivery remain aligned with business objectives, regulatory requirements, and compliance standards.
Collaborate with regulatory stakeholders across global regions to elicit, analyze, validate, and document business requirements, ensuring requirements are clear, complete, and actionable.
Partner effectively with business users, Project Managers, vendors, technical teams, and senior leadership to drive alignment and successful delivery.
Own and manage JIRA product backlogs, creating detailed user stories, defining acceptance criteria, and prioritizing features based on business value, regulatory impact, and organizational priorities.
Work closely with development, QA, regulatory, IT, and business teams to ensure delivered solutions satisfy functional requirements, technical specifications, and applicable regulatory standards.
Facilitate requirements workshops, stakeholder meetings, backlog refinement sessions, and solution discussions, leveraging Confluence for centralized documentation and collaboration.
Lead solution design discussions and evaluate integration requirements with existing regulatory information management and submission management platforms.
Manage the end-to-end delivery of regulatory system enhancements, including requirements planning, development coordination, testing, validation, release management, and deployment.
Ensure solutions comply with applicable pharmaceutical regulatory frameworks, including FDA, EMA, and ICH guidelines, as well as data integrity and GxP requirements.
Collaborate with IT, Quality, Compliance, and Validation teams to manage change controls, system validation, and compliance activities for regulated applications.
Provide strategic guidance and thought leadership on digital transformation, technology adoption, and process optimization within the global Regulatory Affairs organization.
Lead and support User Acceptance Testing (UAT) by developing test scenarios, coordinating execution with business stakeholders, validating outcomes, and ensuring requirements are fully satisfied.
Monitor, triage, and manage UAT defects, collaborating with development and QA teams to prioritize issues and ensure timely resolution.
Actively participate in and facilitate Agile/Scrum ceremonies, including daily stand-ups, sprint planning, sprint reviews, retrospectives, and backlog refinement to maintain team alignment and delivery velocity.
Salary.com Estimation for Technical Product Owner in Raritan, NJ
$110,283 to $135,840
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