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Project Manager - FSP Team - Patient Safety Focused

Thermo Fisher Scientific

Remote · Cambridge, MA, US

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About this role

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description

Seeking a candidate who has demonstrated clinical trial project management experience supporting Global Patient Safety / Pharmacovigilance / Drug Safety.

At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner and safer. Within our Functional Service Provider (FSP) organization, the GPS Functional Project Manager, Process & Operations plays a critical role in supporting the successful delivery of Global Patient Safety (GPS) services by driving operational excellence, leading strategic initiatives, and continuously improving business processes.

This role combines project management, operational leadership, process optimization, and stakeholder engagement to ensure consistent execution of business priorities across global teams. The successful candidate will partner with internal functional leaders, client stakeholders, and cross-functional teams to implement scalable solutions, improve operational performance, and support high-quality service delivery in a regulated environment.   Key Responsibilities Project Management • Lead and manage strategic functional and operational initiatives from planning through implementation. • Develop comprehensive project plans, timelines, milestones, resource plans, risk registers, and success metrics. • Coordinate cross-functional project teams to ensure timely delivery of agreed objectives. • Facilitate governance meetings, project workshops, and stakeholder reviews. • Identify project risks, issues, dependencies, and mitigation strategies while escalating critical decisions when appropriate. • Prepare executive-level project updates, dashboards, status reports, and presentations. • Ensure projects align with Thermo Fisher Scientific operational standards, client expectations, and business objectives.  

Process & Operational Excellence • Evaluate, document, and optimize operational workflows across Global Patient Safety functions. • Lead process mapping, gap analysis, and continuous improvement initiatives to enhance efficiency and quality. • Develop standardized operating procedures, process documentation, templates, and best practices. • Define and monitor operational performance indicators (KPIs) and process effectiveness metrics. • Support implementation of sustainable process improvements through change management activities. • Promote a culture of operational excellence, standardization, and continuous improvement.  

Knowledge Management & Business Operations • Maintain operational knowledge repositories, SharePoint sites, collaboration platforms, and business documentation. • Ensure onboarding materials, training resources, governance documentation, and functional communications remain current and accessible. • Coordinate inputs from subject matter experts to maintain accurate operational content. • Support business planning activities, governance forums, leadership meetings, and operational communications. • Track recurring operational deliverables and ensure timely completion of business commitments. • Champion effective utilization of project portfolio management and collaboration tools.

Stakeholder Engagement • Build collaborative relationships with internal functional leaders, delivery teams, quality, technology, and client stakeholders. • Facilitate effective communication across global, cross-functional teams. • Translate business requirements into practical project plans and operational solutions. • Provide leadership in coordinating complex initiatives across multiple functions. • Influence stakeholders through strong communication, organization, and problem-solving skills.  

Qualifications Minimum Requirements • Bachelor's degree in Life Sciences, Pharmacy, Healthcare, Business, Public Health, Engineering, or a related discipline. • Minimum 5 years of experience within pharmaceutical, biotechnology, CRO, healthcare, or life sciences organizations. • Minimum 3 years of project management, PMO, business operations, process excellence, or consulting experience. • Demonstrated success leading cross-functional projects within complex global organizations. • Experience with business process mapping, process redesign, and continuous improvement methodologies. • Excellent stakeholder management, communication, and presentation skills. • Strong organizational skills with the ability to manage multiple priorities simultaneously. • Advanced proficiency with Microsoft Office Suite, Microsoft Teams, SharePoint, and project management tools. • Knowledge of project portfolio management systems (e.g., Planisware, Smartsheet, MS Project, or similar). • PMP certification or equivalent project management certification preferred.

Preferred Qualifications • Experience supporting Global Patient Safety, Pharmacovigilance, Drug Safety, Clinical Development, Regulatory Affairs, Medical Affairs, or other GxP-regulated functions. • Experience within Functional Service Provider (FSP) or Contract Research Organization (CRO) environments. • Experience supporting global client partnerships and matrix organizations. • Lean Six Sigma or continuous improvement certification is advantageous. • Experience with organizational change management or business transformation initiatives.  

Core Competencies • Project & Program Management • Operational Excellence • Business Process Improvement • Continuous Improvement • Stakeholder & Client Management • Change Management • Risk & Issue Management • Governance & Business Operations • Strategic Planning & Execution • Communication & Influencing • Cross-functional Leadership • Quality & Compliance • Analytical Problem Solving  

What We Offer At Thermo Fisher Scientific, you'll join a global organization committed to advancing science and improving patient outcomes. We provide opportunities to work alongside industry-leading experts, support world-class pharmaceutical and biotechnology partners,

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