Country Approval Specialist

3 weeks ago


Kuala Lumpur, Malaysia Thermo Fisher Scientific Full time

Ensures the submission process for sites and studies are aligned to the critical path for site activation. Prepares Regulatory Compliance Review packages, as applicable, as well as liaising within SIA locally to ensure the local submission activity is planned and delivered in accordance with the global project submission strategy. In addition, develops country and site specific Patient Information Sheet/Informed Consent form documents.

Coordinates with internal functional departments, to ensure various site start-up activities are aligned with submission activities and mutually agreed upon timelines. Ensures the submission process for sites and studies are aligned to the critical path for site activation. Has contact with investigators for submission related activities and serves as a key contact at country level for either Ethical or Regulatory submission related activities. Achieves PPD target cycle times for site. Prepares Regulatory Compliance Review packages, including working with the SIA CRA as applicable.



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