Work Schedule
Standard Office Hours (40/wk)
Environmental Conditions
Office
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.
