Amendment Implementation Specialist
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Bulgaria
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Tech Stack
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
audit processinspection processdata analysisproject managementrisk identificationcontingency planningamendment implementationforecasting
Soft skills
organizational skillsattention to detailcustomer focuscollaboration skillsnegotiation skills
Certifications
Bachelor's degree