Work Schedule

Environmental Conditions

Job Description

Experience managing REMS programs is STRONGLY PREFERRED for this opening.

Brief description:
Leads cross-functional, strategic Risk Evaluation and Mitigation Strategy (REMS) and risk management projects while also leading internal projects and process improvement initiatives. Solves complex problems; takes a new perspective using existing solutions. Works independently and receives minimal guidance.

What You'll Do:

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

Education & Experience Requirements:

Bachelor's degree or equivalent

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5-8+ years)

Knowledge, Skills, Abilities:

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

Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.