FSP Essential Document Pack (EDP) Reviewer (Open)
RemoteMexico
MexicoRemoteFull TimeLarge
Full TimeLarge
Job Summary
Review country and site essential documents for completeness, accuracy, and quality using the Essential Document Compliance (RDC) checklist. Notify EDP Submitters via email of review outcomes, detailing requested revisions or corrected documents when deficiencies are noted. Review revised packs to ensure deficiencies were resolved and communicate results to the SSU Specialist. Track all EDP review details in the applicable data tracking system while maintaining knowledge of SOPs, client directives, and current regulatory guidelines.
Required Qualifications
- Bachelor's degree
- 2+ years experience
- Good English language (written and oral) communication skills
- local language where applicable
- Good attention to detail and quality
- editorial/proofreading skills
- Good computer skills including the use of Microsoft Word, Excel, Power Point
- capable of learning new technologies
- Basic organizational, time management, and planning skills
- Good negotiation skills
- Capable of working independently with direction and exercising independent judgment
- Capable of independently assessing sponsor regulatory needs
- Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
- Basic understanding of medical terminology, statistical concepts, and guidelines
- Good analytical, investigative and problem-solving skills
- Capable of interpreting data
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