Job Overview

Primary contact with investigative sites during study maintenance and -when assigned-, site startup activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and 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 of Regulatory Authority submissions (...