Key Responsibilities

• Manage & provide oversight for global public disclosure of clinical trial data/information in compliance with various requirements/commitments, including, but not limited to, CTIS, EUDAMED, EU Clinical Trial Regulation, EU Medical Device Regulation, EU In-vitro Device Regulation, EMA Policies 0043 & 0070, & PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing.
• Investigate & gather global requirements & implement processes for ensuring accuracy, consistency, & alignment of clinical data/information made public.
• Work globally & cross functionally to align procedures & ensure appropriate compliance.