PIM Technical Analyst

P4-12448

Key Responsibilities:

1. Release Planning & Technical Assessment

• Participate in PIM release planning to define and scope technical deliverables.
• Conduct technical feasibility assessments for fit-gap solution options.
• Contribute to validation strategy planning, particularly for Operational Qualification (OQ).
• Author and contribute to System Design Specifications (SDS) for PIM releases.

2. System Configuration & Enhancement

• Configure Oracle Cloud PDH environments (non-production and production).
• Enable users to maintain Global UDI attributes for markets including EU, China, South Korea, Saudi Arabia, US, Taiwan, Singapore, and Australia.
• Incorporate system review feedback to enhance application functionality.
• Enhance the Marketing Solution set to support new locales and feed BD marketing websites.

3. Cross-Functional Collaboration

• Collaborate with Regulatory Affairs, Marketing, and Environment Health & Safety (EHS) teams to align data standards and processes.
• Work with the Integration Team to design, develop, and support inbound/outbound integrations between Oracle Cloud PDH and enterprise systems.

4. Regulatory Compliance & Data Governance

• Configure and support Cloud PDH for UDI data submission to global regulatory bodies including EUDAMED and US FDA via Reed Tech.
• Establish and maintain a data governance framework in Cloud PDH, including setup of Change Orders, New Item Requests, and Item Business Rules.

5. Reporting & Visualization

• Build interactive reports and dashboards to visualize regulatory data, compliance timelines, data completeness scores, and submission readiness.

6. Validation & Testing

• Document and execute IQ test scripts; support OQ and PQ validation activities.
• Participate in system verification and validation activities across IQ, OQ, and PQ phases.
• Document System Configuration Workbook and Oracle Web Services Instructions tailored to BD s integration needs.

7. Deployment & Support

• Support PIM cutover, deployment, and hypercare activities.
• Conduct knowledge transfer sessions and assist in post-implementation stabilization.
• Support the AMO team in resolving business-critical, time-sensitive issues.
• Assist the PIM Business team with project-related and ad hoc activities, including data migration and onboarding.

Qualifications:

• Hands-on experience with Oracle Cloud PDH and PIM systems.
• Strong understanding of global UDI requirements and life sciences regulatory frameworks.
• Proficiency in system configuration, integration design, and validation documentation.
• Excellent collaboration and communication skills across technical and business teams.

Required Skills

Optional Skills

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