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