Project Manager, REMS Team

Job not on LinkedIn

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👷‍♀️ Project Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Serve as the Project Lead and primary sponsor contact • Accountable for overall project delivery, including quality, time, and cost • Establish and communicate customer expectations to the project team • Lead cross-functional project teams to meet or exceed deliverables • Serve as the primary contact between the sponsor and the organization at project level • Ensure internal and external escalation pathways are followed • Define responsibilities and communication pathways for secondary project leads and vendor or delivery-subset leads where required • Demonstrate financial stewardship through contract understanding, resource alignment to budget, out-of-scope activity management, change modification negotiations, and timeline execution • Drive risk identification and issue resolution at project level using RBQM/RESOLVE • Ensure project team compliance with organizational policies, SOPs, ICH-GCP, regulatory, and project-specific requirements

🎯 Requirements

• Position requires 3-5+ years of demonstrated REMS (Risk Evaluation Mitigation Strategy) Project Management experience within a CRO/Pharma/Biotech environment • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 8+ years • Technical and systems competency, including Microsoft Outlook, Word, Excel, PowerPoint, CTMS, Preclarus, and Clarity • Ability to delegate and prioritize project team workloads in a frequently changing environment • Effective oral and written communication and presentation skills • Proactive, solutions-oriented, and adaptable to changing priorities and situations • Advanced therapeutic area knowledge and clinical development guidelines and directives • Strong understanding of project management principles, including time, quality, cost, and financial acumen • Interpersonal and customer service skills, including leading, motivating, and coordinating cross-functional project teams • Judgment, decision-making, critical thinking, and analytical strategic thinking skills • Ability to negotiate, persuade, and influence others, including cross-cultural awareness • Ability to ensure compliance with organization policies, SOPs, ICH-GCP, regulatory, and project-specific requirements

🏖️ Benefits

• Collaboration and development opportunities • Global team environment • Opportunities to contribute to scientific excellence and innovation