Amendment Implementation Specialist

November 22

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Description

• Completes amendment activities within assigned projects • Ensures amendment deliverables meet customer expectations • Supports amendment implementation strategy at country and site levels • Collaborates with project team on amendment planning • Discusses financial coverage for the amendment • Tracks amendment related actions • Schedules progress check calls with local teams • Updates Principal Investigator Amendment Notification and Implementation Letters • Liaises with the Regulatory Affairs Lead for submission requirements • Informs project team when amendment activities are completed

Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • Comparable to 2+ years experience • Very good understanding of PSC tasks, applicable PSCs' and other manuals, eTMF and File Review processes • Audit/inspection process awareness with relevant rules and guidance documents • Expert knowledge of an application (e.g. Excel), system or process • Good organizational skills and strong attention to detail • Ability to effectively analyze project-specific data/systems • Analytical skills • Strong customer focus • Flexibility to reprioritize workload to meet changing project timelines • Knowledge of ICH GCP, strong comprehension of applicable SOPs • Good understanding of a clinical trial life cycle • Advanced English (verbal & written) • Good computer skills, proficient in several MS Office • Strong collaborators, very good communication skills • Ability to work in a team or independently • Good negotiation skills • Must be able to multi-task • Exposure to high pressure • Attention to details

Benefits

• Competitive remuneration • Annual incentive plan bonus • Healthcare • Range of employee benefits