FSP - Regulatory and Start-Up Specialist in Brazil

IQVIA; São Paulo; Teletrabalho; BRL 60.000 - 90.000; Tempo integral

Resumo da oferta

A leading global provider in clinical research, IQVIA is hiring a Regulatory and Start-Up Specialist in Brazil. This home-based role focuses on site activation tasks, ensuring compliance with local and international regulations. The ideal candidate will have a degree in Life Sciences and 1-3 years of relevant experience in Regulatory activities.

Qualificações

• 1-3 years of experience in Regulatory and Start-up activities.
• Advanced level of English required.

Responsabilidades

• Serve as SPOC in assigned studies for site activation and regulatory activities.
• Prepare and review site regulatory documents for accuracy and completeness.
• Track and review progress on approvals of regulatory and contractual documents.

Conhecimentos

ICF customization

Experience with ANVISA

Regulatory knowledge

Project Management

Formação académica

Bachelor's degree in Life Sciences

Descrição da oferta de emprego

FSP - Regulatory and Start-Up Specialist in Brazil

Join to apply for the FSP - Regulatory and Start-Up Specialist in Brazil role at IQVIA.

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. Maintenance activities may also be included.

Essential Functions

1. Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to SOPs, WIs, quality of deliverables, and project timelines.
2. Perform start-up and site activation activities according to regulations, SOPs, and work instructions. Distribute completed documents to sites and internal team members.
3. Prepare site regulatory documents, reviewing for completeness and accuracy.
4. Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
5. Review and provide feedback on site performance metrics.
6. Review, establish, and agree on project planning and timelines. Ensure monitoring measures are in place and implement contingency plans as needed.
7. Inform team members of the completion of regulatory and contractual documents for individual sites.
8. Track, review, and follow up on the progress, approval, and execution of documents, including regulatory, ethics, ICF, and Investigator Pack release documents, in line with project timelines.
9. Provide local expertise to SAMs and the project team during initial and ongoing project planning.
10. Perform quality control of documents provided by sites.
11. May have direct contact with sponsors on specific initiatives.

Qualifications

• Bachelor's degree in Life Sciences is preferred.
• 1-3 years of experience in Regulatory and Start-up activities:
• ICF customization
• Submission of amendments to Centro Coordenar and CONEP, and to all participant sites
• Experience with ANVISA
• Advanced level of English
• This is a home-based role.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of medical treatments to improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com