Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
1 Year
Description
- Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required.
- Participate in company start-up initiatives, contributing to development and maintenance of Regulatory Start Up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements.
Qualifications
Highest qualification: University
- Graduate in a clinical, pharmacy or life sciences related field.
- At least 1 years Regulatory Start Up experiences in local the clinical industry.