Job Description
Job Overview
Under general supervision, perform activities at a country/region level associated with import and export processes for clinical trials, in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), and project requirements. Responsibilities include feasibility assessments, regulatory submissions, and maintenance activities related to investigational product (IP) logistics.
Essential Functions
- Execute import/export feasibility, regulatory submissions, and maintenance activities for assigned studies, ensuring compliance with applicable regulations, SOPs, and work instructions.
- Prepare and review import/export documentation, ensuring completeness, accuracy, and compliance with regulatory and customs requirements.
- Track, coordinate, and follow up on approvals and execution of import/export-related documents, including licenses, permits, and IP release documentation.
- Ac...