Amendment Implementation Specialist

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Thermo Fisher Scientific

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Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Supports the amendment implementation strategy at country and site levels, within a region or globally • Collaborates with project teams on amendment planning • Tracks amendment related actions • Updates Principal Investigator Amendment Notification and Amendment Implementation Letters • Prepares and distributes the Amendment Progress Report and other applicable study reports

🎯 Requirements

• Supports understanding of amendment scope, classification and timelines • Supports requests of country resources in Clarity • Collaborates with project teams on amendment planning • Discusses financial coverage for an amendment with the Project Lead • Tracks amendment related actions and facilitates updates within applicable system(s) • Schedules and conducts progress check calls with project teams • Updates Principal Investigator Amendment Notification and Amendment Implementation Letters • Liaises with the Regulatory Affairs Leads and project teams to assess amendment’ submission requirements and country submission timelines • Prepares and distributes the Amendment Progress Report and other applicable study reports to project teams to act on compliance gaps as applicable, directly in systems, providing a deadline for feedback • Updates forecasting and actuals for amendment related units according to Clarity monthly deadlines • Informs project team members when amendment activities have been completed • Supports risk identification and contingency planning pertaining to amendments • Introduces roles and responsibilities to project team • Requests access to study related systems

🏖️ Benefits

• Reasonable accommodation to participate in the job application or interview process • Essential job functions support