Senior Regulatory & Start Up Specialist, Cfsp

IQVIA Inc

Mexico
Fully remote
Site qualification and green light
Essential document collection and tracking
Ethics committee and regulatory authority submissions
IQVIA Inc is seeking a Senior Regulatory & Start Up Specialist for a fully home-based role in Mexico. The position involves overseeing end-to-end site management, regulatory submissions, and supporting site maintenance activities within the biopharmaceutical/CRO industry

Job Summary

  • This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members.
  • Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to study and site activity.
  • Support the collection of country and site level intelligence and Ethics Committee and Regulatory Authority submissions.

Matching Summary

Match Score: 85

IQVIA Inc is seeking a Senior Regulatory & Start Up Specialist for a fully home-based role in Mexico. The position involves overseeing end-to-end site management, regulatory submissions, and supporting site maintenance activities within the biopharmaceutical/CRO industry.

Skills & Requirements

Must-have

  • site qualification and green light
  • essential document collection and tracking
  • Ethics Committee and Regulatory Authority submissions
  • country and site-specific activities
  • Veeva Vault proficiency

Nice-to-have

  • goal oriented and self-starter
  • proactively identify issues and provide solutions
  • detail oriented and manage multiple tasks
  • good interpersonal skills

Key Requirements

  • Bachelor’s Degree or equivalent experience
  • Minimum of three years relevant experience
  • EC submission experience in Mexico
  • ICF customization experience
  • Fluent English
  • Ability to negotiate complex contracts

Work Rights

Not specified

Tailored Resume

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