FSP Country Approval Associate

Job Title: FSP Country Approval Associate Job Location: Remote, North Carolina, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Country Approval Associate - Make an Impact at the Forefront of Innovation The Country Approval Associate supports the preparation, review and coordination of Country Submissions in line with global submission strategy. What You'll Do: Prepare, review and coordinate, under guidance and local EC submissions in alignment with global submission strategy. •Support preparation, under guidance, of local MoH submissions, as applicable in •alignment with global submission strategy. •Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation. •Achieve company’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. •Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. •Assist in developing country specific Patient Information Sheet/Informed Consent form documents. •Assist with grant budgets(s) and payment sc