responsible for quality deliverables at the country level; follows project requirements and applicable country rules, with minimal oversight from the ssu country manager.
forecasts submission/approval timelines, ensures compliance and tracks milestone progress in agreed upon ssu tracking system in real time; if forecasted timelines are not reached analyses data to provide clear rationale for delays, provides contingency plans to mitigate impact, and escalates the issue as soon as identified.
monitors financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
reviews and complies with standard operating procedures (sops) and work instructions (wis) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.

local submissions specialist
follows the project direction and expertise provided by the designated country start-up advisor (csa) and pm/sam.
may serve as the primary point of contact for the pm/sam (or designee) during start-up on allocated projects.
compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from site.
prepares and submits central ec applications, local ec applications, ra applications, and other local regulatory authorities or hospital approval submissions as required.
oversees ongoing submissions, amendments, and periodic notifications required by central and local ec and ra, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with minimal oversight from the ssu country manager.
may act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues.
oversee site activation end to end process at country/ site level.

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself.

Senior Site Start-Up & Regulatory Specialist

About this role