Regulatory and Start Up Specialist

職位要求

• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Review and manage collection of essential documents required for site activation/IMP release.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• At least 2 years of relevant experience.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Candidates must be legally authorized to work in the country of employment without employer sponsorship.

原文資格條件

以下摘錄自招聘來源，適用條件請以原文為準。

• Candidates must be legally authorized to work in the country of employment without employer sponsorship.