Brief Description
Seeking an experienced Senior Project Manager to lead delivery across three concurrent, equal-priority GxP safety-system technology initiatives: the Oracle Argus upgrade, the RxLogix PV Intake upgrade, and the Safety Database Japan Enablement / Implementation. The selected candidate will report directly to Jiten Patel within DEC R&D Safety Systems / Pharmacovigilance Technology portfolio.
This role requires a seasoned PM who can establish planning discipline, stakeholder alignment, vendor coordination, RAID management, and governance across all three workstreams from the outset. All three initiatives are transitioning from initiation into planning, and the PM is expected to take immediate, independent ownership of project delivery with hands-on management and cross-functional coordination.
Project Planning & Delivery
• Establish and maintain integrated roadmaps, project plans, timelines, and milestone views across the Oracle Argus upgrade, RxLogix PV Intake upgrade, and Safety Database Japan Enablement / Implementation workstreams.
• Drive projects from initiation through planning and into execution with structured, repeatable PM discipline suited to regulated GxP technology environments.
• Identify, schedule, and track project deliverables, milestones, and required activities across all three concurrent workstreams.
• Manage cross-workstream dependencies, sequencing, and integration points to ensure cohesive delivery.
Governance, RAID & Reporting
• Own and maintain a comprehensive RAID log covering risks, issues, actions, decisions, vendor dependencies, and cross-workstream constraints.
• Produce consistent, executive-ready project status reports, governance updates, and steering committee materials.
• Prepare and deliver leadership updates, decision summaries, and escalation materials as required.
• Maintain a vendor artifact tracker, vendor deliverable oversight log, and integrated launch-readiness view.
• Establish and enforce standards and procedures for project reporting and documentation aligned with DEC PMO expectations.
Stakeholder & Vendor Management
• Lead cross-functional stakeholder coordination across business, technology, compliance, security, operations, vendor partners, and senior leadership.
• Drive stakeholder alignment sessions, facilitate governance meetings, and broker consensus across functions with competing priorities.
• Oversee vendor coordination, deliverable tracking, and dependency management to ensure third-party contributions stay on schedule.
• Serve as primary escalation point for workstream blockers, proactively surface risks and recommended mitigations to the hiring manager and project stakeholders.
Team & Resource Coordination
• Assign duties and define scope of authority for project contributors; direct and coordinate activities to keep initiatives on schedule and within budget.
• Review status reports prepared by workstream participants and modify plans as required to maintain delivery momentum.
• Provide leadership, structure, and direction to project teams and vendor partners throughout the project lifecycle.
Continuous Improvement
• Benchmark project management performance across all three workstreams to identify improvement opportunities and increase governance maturity.
• Apply appropriate frameworks (Lean, Agile, ADKAR, risk management) to reduce inefficiencies and improve delivery quality in a regulated pharma environment.
Required Knowledge, Skills & Abilities
Education
• Bachelor’s or master’s degree in computer science, information systems, life sciences, project management, business management, or a related field. Equivalent professional experience in regulated IT / pharma technology delivery will be considered.
• PMP, PMI-ACP, PRINCE2, SAFe, or equivalent project management certification is strongly preferred.
Experience – Must-Have
• 5+ years of senior project management experience leading complex technology delivery across multiple concurrent workstreams in a regulated industry environment.
• Demonstrated experience in pharma, biotech, life sciences, or a comparable regulated industry (GxP awareness required; direct QA ownership is not required).
• Proven experience managing GxP safety-system, pharmacovigilance, or regulated application upgrade, integration, or implementation projects.
• Experience delivering in DEC / IT environments with comfort managing regulated application upgrades, system integrations, and multi-vendor implementations.
• Demonstrated capability producing executive-ready governance materials including status reports, steering committee content, and escalation packages.
• Experience managing comprehensive RAID logs and dependency tracking across cross-functional, multi-vendor project environments.
• Track record of independent project ownership with hands-on delivery management – not a coordinator role.
Experience – Preferred / Nice-to-Have
• Direct hands-on experience with Oracle Argus safety database upgrades or implementations.
• RxLogix PV Intake upgrade or implementation experience.
• Clarity PPM proficiency for roadmap and project tracking.
• Safety database regional enablement or implementation experience (Japan or other APAC markets).
• Hybrid Agile delivery experience (Scrum, Kanban, SAFe) in a regulated pharma technology context.
• Familiarity with Jira, Confluence, or Azure DevOps in a project delivery context.
Knowledge & Skills
• Deep familiarity with project management methodologies (PMI PMBOK, PRINCE2, Agile / Scrum, SAFe, hybrid) with ability to adapt approach to GxP constraints.
• Strong understanding of GxP regulatory requirements as they apply to safety-system technology delivery; direct validation ownership not required.
• Exceptional verbal and written communication skills with demonstrated ability to translate complex delivery status into clear, leadership-ready narratives.
• Proficiency with Microsoft 365 (Teams, SharePoint, PowerPoint, Excel) for collaboration, governance, and reporting.
• Clarity PPM proficiency preferred; familiarity with Jira, Confluence, or Azure DevOps is helpful.
• Effective influencing, negotiating, and consensus-building skills in an environment where the role does not directly control all resources.
• Strong understanding of vendor management, contract deliverables tracking, and third-party dependency oversight.
• Ability to develop and execute a project resource plan ensuring the right contributors are engaged at the right time across concurrent workstreams.
• Sensitivity to working in a politically complex, highly regulated environment with senior pharmaceutical leadership.
Key Deliverables & Success Measures
• Integrated roadmap, project plans, timelines, and milestone views covering all three safety-system workstreams.
• RAID log and dependency / decision tracking log covering risks, issues, actions, decisions, vendor dependencies, and cross-workstream constraints.
• Consistent project status reports, governance updates, and executive-ready summaries on a regular cadence.
• Steering committee support packages including leadership updates, decision summaries, and escalation materials.
• Vendor artifact tracker, vendor deliverable oversight log, integrated launch-readiness view, and decision log.
• Demonstrated project health, timeline adherence, dependency resolution, and governance evidence throughout the engagement.
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