Essential Functions [담당업무]
• Supports the preparation of documentation and submissions under guidance
• Coordinates and manages client deliverables supporting regulatory compliance
• Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting
• Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines
• Assists in business development and pricing of projects for the department
• Evaluates client needs in relationship to overall project timelines, quality and delivery
• Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed.

Education and Experience [지원자격]
• 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 2+ years)
• Good English language (written and oral) communication skills as well as local language where applicable
• Good attention to detail and quality as well as editorial/proofreading skills
• Good interpersonal skills to work effectively in a team environment
• Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Good negotiation skills
• Capable of working independently with direction and exercising independent judgment
• Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables
• Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management