Work Schedule

Environmental Conditions

Job Description

· Supporting in the preparation and filing of regulatory documents across the study lifecycle, including but not limited to:

o Protocol and data collection tool development

o Translation requests

o Deviation reports

o Continuing review requests and site closure requests

· Supporting quality and compliance-related work at the study level, including but not limited to:

o Verifying completeness of site master files and maintaining over the course of the study

o Performing document control including versioning, filing, and archiving of controlled study documents and Standard Operating Procedures

o Answering site-related compliance questions

· Support Quality & Regulatory Compliance Team in regulatory matters.

· Attending team meetings; taking notes and tracking departmental action items

· Performs other duties as assigned.