Regulatory and Start-Up Specialist

hace 2 semanas

Buenos Aires, Buenos Aires C.F., Argentina Iqvia Argentina A tiempo completo
Job Description

The Sr. Regulatory and Start-Up Specialist will 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 guidelines.

This role is responsible for ensuring adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.

The successful candidate will have excellent communication and organizational skills, as well as the ability to work independently and as part of a team.

Key Responsibilities:

  • Perform feasibility, site ID, start up, and site activation activities according to applicable regulations, SOPs, and work instructions.
  • Distribute completed documents to sites and internal project team members.
  • Prepare site documents, reviewing for completeness and accuracy.
  • 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.
  • Inform team members of completion of feasibility, site ID, regulatory, and contractual documents for individual sites.
  • Review, track, and follow up the progress, approval, and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
  • Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
  • Perform quality control of documents provided by sites.

Qualifications:

  • Bachelor's Degree in Life Science or related field.
  • 3 years' of relevant experience working in the regulatory department in Argentina.
  • Advanced level of English.
  • Ability to work independently.

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