Project Manager, Risk Management Programs (REMS)

Thermo Fisher Scientific•Wilmington, NC

19h•Onsite

About The Position

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.

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

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