Job Overview
Collaborate with peers across the organization to achieve client-centric delivery in a matrix organization. Collaboration across all stakeholders within Site Readiness. Oversight and accountability of Regulatory Authority (RA), Independent Review Board (IRB)/Ethics Committee (EC) and Third Body submissions for designated projects within Site Readiness.
Summary Of Responsibilities
- Oversight and accountability for RA, IRB/EC, and Third Body submissions, including submission strategy, timeline, planning, and delivering to the agreed upon timelines by tracking submission/approval timelines against projected milestones within relevant systems. Coordinate responses to queries and ensure the required timelines are met. Provides consolidated country requirements and regular status updates to project team and Client, as applicable. May be assigned to smaller projects in terms of size and complexity in regional and/or global role.
- Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and client requests by preparing,
reviewing, and providing input to core study documents as applicable. This may include the compilation, review and distribution of core package, QC of core package, and country packages, maintenance and close out.
- Provide the highest quality advice on regulatory issues to members of project teams and its clients by maintaining awareness of current regulatory legislation, guidance and practice related to RA, IRB/EC, and Third Body submissions. Evaluate the impact of clinical/regulatory changes on assigned product.
- Liaise with and/or support local teams to liaise with RA, IRB/EC, and Third Bodies on behalf of clients.
- Where applicable and if suitably experienced, provide guidance and regulatory expertise on the application of the EU CTR in CTIS to other stakeholders. Manage applicable user access to CTIS and act as back up in case of unexpected absences of other team members.
- Review and in