Thermo Fisher Scientific

Amendment Implementation Specialist

Thermo Fisher Scientific

full-time

Posted on:

Location Type: Remote

Location: Bulgaria

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Tech Stack

Google Cloud Platform

About the role

  • Completes amendment activities within assigned projects
  • Ensures amendment deliverables meet customer expectations
  • Supports the amendment implementation strategy at country and site levels
  • Collaborates with project teams on amendment planning
  • Tracks amendment related actions
  • Schedules progress check calls with project teams
  • Liaises with Regulatory Affairs Leads
  • Prepares and distributes the Amendment Progress Report
  • Updates forecasting for amendment related units
  • Supports risk identification and contingency planning

Requirements

  • Bachelor's degree or equivalent
  • Previous experience in relevant field
  • Audit/inspection process awareness
  • Expert knowledge of application, system or process
  • Good organizational skills and attention to detail
  • Ability to analyze project-specific data/systems
  • Strong customer focus
  • Knowledge of ICH GCP and clinical trial life cycle
  • Good computer skills, proficient in MS Office
  • Strong collaboration and negotiation skills
  • Comprehensive understanding of clinical research/development
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible working hours
  • Paid time off
  • Remote work options
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
audit processinspection processdata analysisproject managementrisk identificationcontingency planningamendment implementationforecasting
Soft Skills
organizational skillsattention to detailcustomer focuscollaboration skillsnegotiation skills
Certifications
Bachelor's degree