Project Manager, REMS Team - Remote based in the US

Thermo Fisher Scientific is a global team committed to scientific excellence, innovation, and collaboration. The Project Manager leads REMS cross-functional projects, serves as the primary sponsor contact, and is accountable for quality, time, cost, financial stewardship, risk management, issue resolution, and compliance with organizational and regulatory requirements.

Responsibilities:

• Serve as the primary contact between the sponsor and the organization at the project level
• Ensure escalation pathways adhered to internally and externally (Rules of Engagement – communication pathways)
• On projects where the scope requires, ensure clear delineation in responsibilities and communication pathways for secondary project leads, lead for a specific vendor(s) or subset of delivery)
• Accountable for the overall delivery of the cross-functional project (time, cost, quality)
• 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 Con Mod process/negotiations and team execution to timelines
• Establish, communicate and manage customer expectations to achieve optimal delivery during the project
• Drive Risk Identification and Issue Resolution at project level (RBQM/RESOLVE)
• Ensure project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements

Requirements:

• Position REQUIRES 3-5+ years of demonstrated REMS (Risk Evaluation Mitigation Strategy) Project Management experience within a CRO/Pharma/Biotech environment.
• • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years')
• • Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity)
• • Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment
• • Effective oral and written communication and presentation skills
• • Proactive, solutions oriented and adaptable to changing priorities and situations
• • Advanced therapeutic area knowledge and clinical development guidelines and directives
• • Strong understanding of the key principles of project management (time, quality, cost), including solid financial acumen
• • Sound interpersonal and customer service skills, including the ability to lead, motivate and coordinate cross-functional project teams
• • Good judgment and decision making skills and capable of applying critical and analytical strategic thinking skills to manage complex/ambiguous situations
• • Ability to negotiate, persuade and influence others, including a cross cultural awareness