Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Essential Functions and Other Job Information:
Responsible for the preparation of 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 act as a key contact at country level for Ethical or Regulatory submission related activities.
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Prepare Regulatory Compliance Review packages.
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years)
Working Conditions and Environment:
• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.