o Responsible for assisting company in achieving submission of INDs, amendments, briefing packages, responses to questions, and other US Health Authority submissions.
o Accountable for ensuring ex-US clinical trial related submissions are submitted on schedule by local company affiliates or relevant contract research organizations (CROs).
o Assist in execution and oversight of day-to-day activities for assigned projects; ensure regulatory submission deliverables are provided, as needed.
o Attend project-related meetings such as clinical trial execution team and global regulatory team meetings
o Liaise with Global Submission Management and Regulatory Operations Publishing to coordinate health authority submission preparation and dispatch.
o Other mutually agreed upon activities that may or may not be directly related to the assigned projects.
Contract start date: as soon as feasible
Contract duration (18 month max): 6 months
Location: Primarily remote work, may be 1... meeting quarterly in company Boston offices