Zixian Tang Email & Phone Number

Singapore

Singapore

Singapore

Singapore

Singapore

• Develop submission strategy and coordinate submissions to Regulatory Agency, Central Independent Ethics Committee, and other central or country level authorities to achieve timely start-up
• Prepare and QC review country submission packages to ensure they meet the needs of the trial protocol, sound scientific and therapeutic area principles and any other study requirements
• Create / review Master IMP labels, and coordinate development of country-level labels in adherence with Annex 13 or applicable regional requirements
• Support Business Development with regulatory input on Request-for-proposals as required

Singapore

• On assignment to GlaxoSmithKline
• Supports data management activities for regulatory activities for both planning and tracking in the Regulatory Planning Database (RPD, SharePoint), Regulatory Tracking System (RTS, TrackWise) and Change Control.
• Supports document management activities for regulatory documentation, document life-cycle maintenance within the electronic document management (ATLAS and ATLAS Submissions, Livelink; Regulatory Affairs Correspondence.
• Assists in document formatting, style and link checking, preparing paper submissions, maintaining packaging materials, preparing agency forms and general proofreading
• Contributes and actively participates in IT and Business Process Improvement projects to enhance technical functionalities of the systems and in the execution of technical validation tests to verify the correct.
• Provides support to system users to generate and format reports for routine or ad-hoc purposes

Singapore

• On assignment to Novartis Vaccines and Diagnostics
• Supports data management activities for regulatory activities for both planning and tracking in the Regulatory Planning Database (RPD, SharePoint), Regulatory Tracking System (RTS, TrackWise) and Change Control.
• Supports document management activities for regulatory documentation, document life-cycle maintenance within the electronic document management (ATLAS and ATLAS Submissions, Livelink; Regulatory Affairs Correspondence.
• Assists in document formatting, style and link checking, preparing paper submissions, maintaining packaging materials, preparing agency forms and general proofreading
• Contributes and actively participates in IT and Business Process Improvement projects to enhance technical functionalities of the systems and in the execution of technical validation tests to verify the correct.
• Provides support to system users to generate and format reports for routine or ad-hoc purposes

Singapore

• On assignment to Novartis Vaccines and Diagnostics
• Support end users in entering data into CTMS by running training, refresher training and addressing queries and issues.
• Set up and maintain master data in CTMS, as requested by users.
• Perform data quality checks in CTMS to ensure data is consistent, complete and accurate
• Liaise with the appropriate teams and managers when procedural/technical issues are encountered, to address and achieve resolution. Liaise with the CTMS Vendor and IT department as required.
• Provide orientation and guidance on CTMS processes to regional users

Singapore

• Training
• Conduct Face-to-Face / Remote end user training, equiping them with the skills to fully utilize NVD ClinTrack (CTMS) system
• Provide orientaiton and guidance on system SOP, Work Instructions and related processes
• Develop and update training materials for global usersSupport
• Sole regional helpdesk (Asia Pacific, Australia, Africa) supporting on CTMS, MySites and Business Objects Web Intelligence
• Support regional study planning / setup in CTMS