Quintiles and IMS Health have come together to become IQVIA, The Human Data Science Company™ Inspired by the industry we help, IQVIA commits to providing solutions that enable life sciences companies to innovate with confidence, maximize their opportunities and ultimately drive human health outcomes forward.
We provide actionable solutions by tapping into the power of the IQVIA CORE™:
IQVIA is looking for an specialist to join our outstanding RSU team. This person will manage and perform tasks at country level associated with Regulatory, Start-Up (RSU) and Maintenance activities. In addition, may participate in pre-award activities, proposals and oversights of the scope of work at country level.
- Preparation of regulatory submission package to CA/ EC - Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions. - Review, prepare and negotiate site contracts and budgets with sites. - Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed. - Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. - Review and provide feedback to management on site performance metrics. - Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines
Requisitos del candidato
De 1 a 3 años
- Bachelor’s Degree in life sciences - +2 years of experience in RSU (Contract negotiation and Submissions) - Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines - Fluency in spanish and english