Country Approval Assoc

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Description Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy.  • Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. • Coordinates, under guidance, with internal functional departments to ensure  various site start-up activities are aligned with submissions activities and  mutually agreed upon timelines; ensures alignment of submission process for  sites and study are aligned to the critical path for site activation. • Achieves PPD’s target cycle times for site. • May have contact with investigators for submission related activities. • May act as a key-contact at country level for either Ethical or Regulatory  submission-related activities. • Works with the start-up CRA(s) to prepare the regulatory compliance review  packages, as applicable. • Assists in developing country specific Patient Information Sheet/Informed  Consent form documents. • Assists with grant budgets(s) and payment schedules negotiations with sites. • Enters and maintains trial status information relating to SIA activities onto PPD,  or client (where contracted) tracking databases in an accurate and timely  manner • Ensures the local country study files and filing processes are prepared, set up  and maintained as per PPD WPDs or applicable client SOPs. • Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and  current regulatory guidelines as applicable to services provided 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.