PPD Korea에서는 사세 확장으로 아래 포지션에 대해 지원자를 모집하고 있습니다.

만3년 이상 경력을 가진 관심있는 분들의 많은 지원 부탁 드리겠습니다.

지원방법; 영문이력서(CV) e-mail 발송 Dipika.dip@ppdi.com /jinyoung.cho@ppdi.com

Senior Country Approval Specialist

[Essential Job Functions /Responsibilities]

· Prepare, review and coordinate, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy

· Provide, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients,

· Provide project specific local SIA services and coordination of these projects

· May have contact with investigators for submission related activities

· Key-contact at country level for either Ethical or Regulatory submission-related activities

· 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 work with the start-up CRA(s)to prepare the regulatory compliance review packages, as applicable

· May develop country specific Patient Information Sheet/Informed Consent form documents

· May assist with grant budgets(s) and payment schedules negotiations with sites.

· Support the coordination of feasibility activities, as required, in accordance with agreed timelines

· Enter and maintain trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner

· Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs

· Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

[Minimum Required Education and Experience]

· Bachelor's degree

· 3-5 years related experience or equivalent combination of education, training &experience