Job Description
Site Readiness and Regulatory Specialist I
Job Overview
Primary contact with investigative sites during study maintenance and, when assigned, site startup activities, responsible for collecting required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the agreed timelines with project management and the Site Readiness team. Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.
Summary Of Responsibilities
- Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.
- Assist senior staff to compile, prepare, submit, and obtain approval of the submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements.
- Liaise with internal and external vendors in the generation o...