Fsp - Regulatory And Start Up Specialist

IQVIA Inc

São Paulo, Brazil
Hybrid
Site identification
Regulatory start-up activities
Site documentation management
IQVIA Inc is seeking a Regulatory and Start Up Specialist to manage site documentation, regulatory compliance, and performance metrics in São Paulo, Brazil. The ideal candidate will have a Bachelor's degree in life sciences, 1-2 years of regulatory experience in a CRO or pharmaceutical setting, and advanced English communication skills

Job Summary

  • Executes feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level.
  • Prepares and manages site documentation, reviews and negotiates site documents and contracts, and serves as the primary point of contact for investigative sites.
  • Updates and maintains internal systems, databases, tracking tools, timelines, and project plans with accurate project-specific information.

Matching Summary

Match Score: 85

IQVIA Inc is seeking a Regulatory and Start Up Specialist to manage site documentation, regulatory compliance, and performance metrics in São Paulo, Brazil. The ideal candidate will have a Bachelor's degree in life sciences, 1-2 years of regulatory experience in a CRO or pharmaceutical setting, and advanced English communication skills.

Skills & Requirements

Must-have

  • site identification
  • regulatory start-up activities
  • site documentation management
  • site performance metrics
  • investigative site contact
  • contract execution
  • project timelines establishment

Nice-to-have

  • advanced knowledge within discipline
  • great communication skills
  • ability to work in a team

Key Requirements

  • Bachelor's Degree Life sciences or related field
  • 1-2 years experience in regulatory role
  • Experience with CEP/CONEP submissions
  • Experience with ICF local requirements
  • Experience with ANVISA submissions
  • Advanced level of English skills

Work Rights

Not specified

Tailored Resume

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