Lead cross-functional, strategic Risk Evaluation and Mitigation Strategy (REMS) and risk management projects
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
Drive risk identification and issue resolution at project level
Ensure project team compliance with organization policies, SOPs, ICH
GCP, regulatory and project
specific 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
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
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
Ability to plan for and integrate multiple tasks concurrently as well as work independently with minimal direction
Strong understanding of the key principles of project management (time, quality, cost)
Advanced therapeutic area knowledge and clinical development guidelines and directives

Project Manager, REMS Team

Key skills