For AbbVie sponsored clinical studies, to support the Medical Operations Regulatory Manager in preparation, negotiation and execution of Clinical Studies Agreements and in the relevant interaction with AbbVie Departments and external interaction with Administration Offices (AOs) at Public and Private Institutions.
For AbbVie sponsored clinical studies, to provide field support to the study Team for clinical studies submission/updates and follow-up, such as:
optimizing liaison with clinical sites ECs/ AOs
retrieving comments/questions from ECs/AOs in a timely manner and ensuring AbbVie answers are delivered to the right contact
For Investigator’s Initiated Studies to support Med Ops Regulatory Team in relevant IIS activities and for regularly updating the IIS management systems.
For Compassionate Uses (PAA programs), to support Med Ops Regulatory Team ...
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