Senior Project Manager

Required Skills & Experience

Required Qualifications Bachelor's degree in Business, Science, Engineering, Information Systems, or related field. 7+ years of Project or Program Management experience. Experience managing complex cross-functional programs in a regulated life sciences, medical device, or diagnostics environment. Experience building and maintaining integrated project plans and timelines. Strong experience managing milestones, dependencies, risks, issues, and decisions. Experience coordinating deliverables across matrixed organizations. Experience creating project dashboards, databases, trackers, and reporting solutions. Advanced Excel proficiency. Smartsheet experience or Strong MS suite Strong Power BI experience, including dashboard creation and reporting automation. Proficiency with PowerPoint, Teams, SharePoint, and project management tools. Strong communication, facilitation, and stakeholder management skills. Program Management & Execution

Nice to Have Skills & Experience

• Experience with Veeva
• Experience with IVD or In-Vitro

Job Description

Program Management & Execution Lead regulatory registration, product transition, and integration workstreams. Build and maintain integrated project plans, schedules, milestones, dependencies, and RAID logs. Coordinate execution across Regulatory Affairs, Quality, R&D, Labeling, Operations, Supply Chain, Commercial/Marketing, IT, and Integration teams. Facilitate planning sessions, risk reviews, and cross-functional meetings while driving accountability across matrixed teams. Planning & Risk Management Create and manage integrated timelines across multiple workstreams. Identify and mitigate dependencies, resource constraints, planning gaps, schedule conflicts, risks, and issues. Assess impacts of project changes and delays and escalate critical risks and decisions through governance channels. Regulatory Program Support Support product registrations/re-registrations, technical documentation readiness, labeling updates, compliance initiatives, and regulatory submissions. Coordinate regulatory deliverables across functions and partner with Regulatory Affairs, Quality, and R&D to ensure submission readiness and market access. Reporting & Analytics Develop and maintain Power BI dashboards, trackers, and reporting tools. Consolidate data across workstreams and analyze schedule trends, overdue deliverables, and emerging risks. Improve reporting processes through standardization and automation while providing program leadership with status updates and decision-support reporting.