Elizabeth Mendez Roldan

 Prepare, review and coordination of local EC submissions in alignment with the global submission strategy.  Prepare local MoH submissions as applicable, in alignment with the global submission strategy.  Coordinate with internal functional departments to ensure various site start-up activities are aligned with submission activities and mutually agreed upon timelines.  Prepare country and site specific Patient Information Sheet/Informed Consent form documents.  Have contact with investigators for submission related activities or act as a key contact at country level for either Ethical or Regulatory submission related activities.  Responsible for preparing Regulatory Compliance Review packages (Site Activation)  Responsible for preparing Regulatory Compliance Review packages (Studies ongoing-Protocol amendment)  Assist with the development of country specific Patient Information Sheet/Informed Consent form documents with minimal supervision.  Perform start up activities for studies in the following pathology: human papillomavirus  Support for Contract Specialist Team (shipping, following & pick up the final contract trial agreement) Administrative Support on regulatory activities for clinical trials. Control, maintenance and archiving of regulatory documentation, communication with investigation sites.