Work Schedule

Environmental Conditions

Job Description

Responsible for the preparation and reviewing with research centers for local EC submissions and supporting the preparation of MoH (ISP) submissions, as appropriate, according to the submission strategy. 

As applicable, coordinate with others internal functional departments to ensure activities aligned with the submission and site activation strategy and according to the agreed timelines. 

Responsible for preparing and reviewing country and site-specific informed consent forms documents. 

Also have contact with the investigators and the study coordinators for activities related to submissions and acted as a key contact at country level for Ethical or Regulatory submission related activities. 

Prepare Regulatory Compliance Review packages, including working with the CRA as applicable.