Project Manager, REMS Team

Thermo Fisher Scientific

. Serve as the Project Lead and primary sponsor contact .

Posted 9/18/2026full-timeRemote • North Carolina • United StatesSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Project Management within a CRO/Pharma/Biotech environment, with a strong focus on financial stewardship, compliance with ICH-GCP, and effective communication. Proven ability to lead cross-functional teams, manage risks, and ensure project deliverables align with customer expectations.

Highest-signal resume keywords

REMS Project ManagementFinancial StewardshipCross-Functional Team LeadershipRegulatory Compliance (ICH-GCP)Advanced Therapeutic Area Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project Management PrinciplesRisk Identification and ResolutionChange Modification NegotiationsBudget ManagementContract Understanding

Soft Skills

Effective CommunicationJudgment and Decision-MakingCritical ThinkingInterpersonal SkillsAdaptability

Tools & Technologies

Microsoft OutlookMicrosoft WordMicrosoft ExcelMicrosoft PowerPointCTMSPreclarusClarity

Industry Keywords

CROPharmaBiotechSOPsClinical Development Guidelines

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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