Project Manager, REMS Team - Remote based in the US

Thermo Fisher Scientific is a global team that values passion, innovation, and scientific excellence. They are seeking a Project Manager to lead cross-functional Risk Evaluation and Mitigation Strategy (REMS) projects and internal process improvements, ensuring project delivery and compliance with organizational policies.

Responsibilities:

• Serve as the primary contact between the customer and the organization at the project level
• Be accountable for the overall delivery of the cross-functional project (time, cost, quality)
• Ensure escalation pathways are adhered to internally and externally
• Establish, communicate, and manage customer expectations to achieve optimal delivery during the project
• Provide direct support (internal and external) including but not limited to conference calls, meetings, customer problem resolution, audits, and inspections
• Ensure financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of out-of-scope activity, drive the contract modification process/negotiations and team execution to timelines
• Drive risk identification and issue resolution at project level
• Ensure project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project- specific requirements
• Partner with project team to ensure readiness for audit/inspection by a customer or other entity
• Prioritize projects and day-to-day workflow for self and other team members

Requirements:

• Bachelor's degree or equivalent
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5-8+ years)
• Technical and systems competency to include effective use of systems and applications such as Microsoft Outlook, Word, Excel, and PowerPoint, as well as organization applications and platforms
• Ability to delegate and effectively prioritize workload in a frequently changing environment
• Excellent communication (i.e., presentation and written, listening, verbal) and customer service skills, including the ability to lead, motivate and coordinate cross-functional project teams
• Strong analytical, planning, risk and issue identification, and resolution skills required
• Effective communication with internal and external individuals in various functional areas and at all levels of management
• Good judgment and decision-making skills and capable of applying critical and analytical strategic thinking skills to manage complex/ambiguous situations
• Ability to plan for and integrate multiple tasks concurrently as well as work independently with minimal direction
• Ability to negotiate, persuade, and influence others, including a cross-cultural awareness
• Strong understanding of the key principles of project management (time, quality, cost), including solid financial acumen
• Proactive, solutions-oriented, and adaptable to changing priorities and situations
• Advanced therapeutic area knowledge and clinical development guidelines and directives
• Experience managing REMS programs is STRONGLY PREFERRED for this opening