Job Overview:
Collaborate with Site Readiness stakeholders and cross-functional teams to ensure client-centric delivery in a matrix organization. Provide oversight and accountability for Regulatory Authority (RA) submissions and coordinate, as applicable, activities related to Independent Review Board (IRB)/Ethics Committee (EC) and Third Body submissions for designated projects within Site Readiness.
Summary of Responsibilities:
- Provide oversight and accountability for RA submission planning, timeline management, and delivery in accordance with agreed-upon timelines. Support the coordination and tracking of IRB/EC and Third Body submission and approval timelines against projected milestones within relevant systems.
- Coordinate responses to RA queries and ensure that required response timelines are met. Support local and functional teams in coordinating responses to IRB/EC and Third Body queries, as applicable.
- Provide consolidated country requirements and regular status updates to the project team and client, as applicable.
- Ensure that RA submission deliverables comply with 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, distribution, and QC of RA-related core and country packages, as well as package maintenance and close-out activities.
- May be assigned to regional and/or global projects of smaller size and complexity.
- Present at and attend external and internal meetings, including, but not limited to, project core team and client meetings, Pre-Post Award Transition meetings (PPAT), Time Expectations Meetings (TEM), and Kick-Off Meetings (KOM).
- Initiate improvements to enhance the efficiency and quality of the submission work performed on assigned projects.
- Coordinate with local and functional stakeholders to support IRB/EC and Third Body submission activities, as applicable.
- Provide regulatory guidance and advice on regulatory issues related to RA submissions and associated start-up activities by maintaining awareness of current regulatory legislation, guidance, and practices.
- Evaluate the impact of clinical and regulatory changes on assigned projects.
- Coordinate with local teams to support interactions with regulatory authorities, IRBs/ECs, and Third Bodies on behalf of clients.
- Serve as the primary point of coordination for RA-related communications, as applicable.
- Review and provide input into Start-Up project plans.
- Distribute, implement, and monitor compliance with Start-Up project plans for RA submissions and support coordination activities related to IRB/EC and Third Body submissions.
- Ensure RA submission deliverables are met within required timelines while maintaining awareness of Green Light (GL) approval and Ready-to-Enroll (RTE) milestones.
- Support the tracking of IRB/EC and Third Body milestones and proactively identify and escalate to the Start-Up Lead any risks that may affect submission deliverables or site activation timelines.
- Manage projects according to the billing guide to ensure that work is performed within budget. Notify the Start-Up Lead of hours identified as out of scope or projected to exceed the approved budget.
- Proactively engage in both quality assurance and risk management activities to ensure that assigned RA submission deliverables are met and that coordination support for other applicable submission activities is provided as required. Support audits (internal and external) and inspections, as needed. Support resolution of any findings.
- Contribute to the development of the group by participating in process improvement initiatives, such as developing and updating SOPs.
- Mentor more junior Site Readiness team members. Perform any other duties as required by the department.
Qualifications (Minimum Required):
- Bachelor’s Degree in Life Sciences or equivalent.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Working knowledge of ICH-GCP and applicable clinical trial regulations.
- Working knowledge of regulatory authority submission processes is required; familiarity with IRB/EC and Third Body submission processes is preferred.
- Native-level Japanese language skills and business-level English proficiency are required.
Experience (Minimum Required):
- Minimum 4 years of experience in Clinical Trial Start-Up, Regulatory Affairs, Clinical Operations, or Drug Development within the pharmaceutical, biotechnology, or CRO industry.
- Experience managing or coordinating RA submissions is required.
- Experience supporting IRB/EC submissions, site activation activities, or clinical trial start-up activities is preferred.
- Experience with Japan Clinical Trial Notification (CTN) submissions, including the coordination of responses to related PMDA queries, is required.
- Experience supporting investigational medicinal product (IMP) management activities, including importation, customs clearance, depot coordination, and the preparation, review, or approval of clinical trial labels for studies conducted in Japan, is preferred.
Physical Demands/Work Environment:
- Office environment.
- Some flexibility in scheduling may be required.
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