Regulatory Start Up Associate I/II - NZ
Core
Planning, preparation, and review of country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical trials.
Role type
Regulatory Start-Up Associate
Builds
Ethics and regulatory submissions for clinical trial start-up
Domain
Clinical research / Biotech
Deliverable
client delivery
Required skills
Regulatory submission preparation, ICH-GCP compliance, stakeholder balancing, process improvement, document development
Preferred skills
Action-oriented mindset, planning and alignment skills
Technologies
ICH-GCP guidelines
Responsibilities
Develop master and country ICFs, study specific forms, and documents for Central EC/IRB, local EC/Governance, and Regulatory Authority applications; Participate in company start-up initiatives to develop and maintain Regulatory Start Up processes, tools, and SOPs.
Seniority
Entry-level to Junior
