Li Hsin

FAQ About Li Hsin

• What is Li Hsin's address?

  Li Hsin is located at
  Taiwan

• What is Li Hsin's job title?

  Li Hsin is a
  • Develop country ICF and country/site specific documents and communicate with different functional teams directly for assigned studies across several therapeutic area. • Assist in study start-up activities and manage various types of submissions across multiple protocols and therapeutic areas, with strategic plan and time-bound delivery. • Lead a good submission practice (GSP) team and contribute the ideas & effort in good document practice (GDP) team to simplify TMF filing rule and enhance QC process and drive data accuracy lead to inspection readiness and compliance. • Timely upload quality documents for eTMF health and maintain appropriate Clinical Trial Management Systems (CTMS) for assigned studies. • Cooperate and communicate with CRAs and global study team closely for document validation, submission preparation, submission plan setting, timeline achievement and enrollment plan and target. • Support to review and approve the label template and translation for investigatory product per local regulation. • Take responsibility to review and approve the clinical supplies importation (investigatory product and lab kit) for all on-going studies and communicate with cross-functional teams and external vendors to address the issues of import process. • Conduct and centralize clinical supplies importation process and provide the training for team members and newcomers. • Initiate and participate the operation for novel platform or tool to build up data-driven for submission status and progress on our daily work. • Engage in updating the SOP for local investigatory product (IP) destruction/return and affiliate Informed Consent Form and Subject Information Material Version Control and Naming Convention. • Act a buddy and trainer for team’s newcomer. Abbvie

• What industry does Li Hsin currently work in?

  Li Hsin currently works in the
  Abbvie

• What is Li Hsin's area of expertise?

  Li Hsin specializes in
  • Develop country ICF and country/site specific documents and communicate with different functional teams directly for assigned studies across several therapeutic area. • Assist in study start-up activities and manage various types of submissions across multiple protocols and therapeutic areas, with strategic plan and time-bound delivery. • Lead a good submission practice (GSP) team and contribute the ideas & effort in good document practice (GDP) team to simplify TMF filing rule and enhance QC process and drive data accuracy lead to inspection readiness and compliance. • Timely upload quality documents for eTMF health and maintain appropriate Clinical Trial Management Systems (CTMS) for assigned studies. • Cooperate and communicate with CRAs and global study team closely for document validation, submission preparation, submission plan setting, timeline achievement and enrollment plan and target. • Support to review and approve the label template and translation for investigatory product per local regulation. • Take responsibility to review and approve the clinical supplies importation (investigatory product and lab kit) for all on-going studies and communicate with cross-functional teams and external vendors to address the issues of import process. • Conduct and centralize clinical supplies importation process and provide the training for team members and newcomers. • Initiate and participate the operation for novel platform or tool to build up data-driven for submission status and progress on our daily work. • Engage in updating the SOP for local investigatory product (IP) destruction/return and affiliate Informed Consent Form and Subject Information Material Version Control and Naming Convention. • Act a buddy and trainer for team’s newcomer.

• Which languages does Li Hsin speak? 

  Li Hsin speaks the following languages:
  No languages available.

• Which industries has Li Hsin previously worked in?   

  Li Hsin has prior experience in the following industries:
  Eastbamboo

• What is Li Hsin’s work experience?  

  Li Hsin has the following professional experience:
  Abbvie , Eastbamboo , Abbvie .

• How can I find Li Hsin on LinkedIn?  

  You can view Li Hsin’s
  LinkedIn profile at LinkedIn URL.

• What are Li Hsin’s work email addresses?  

  Li Hsin’s work email addresses are
  [email protected] .

• What company does Li Hsin work for?  

  Li Hsin works at
  Abbvie