Job Description
**Job Overview**:
**Summary of Responsibilities**:
- Responsible for maintaining awareness of regulatory legislation, guidance and practice, ICH/GCP and relevant Sponsor requirements.
- Complete submissions to and liaise with IRB/IEC/Third body/Regulatory Authority as applicable regarding submission/approval issues.
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
- Perform a review of final submission documents as applicable.
- Ensure appropriate systems are updated accurately and compliantly, ensuring others follow established processes.
- Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required.
- Mentor and coach other Site Readiness and Regulatory Operations team members.
- ** In-Country specific tasks (Global)**:
- Serve as primary contact for investigative sites and ensure documents required are collected...
**Summary of Responsibilities**:
- Responsible for maintaining awareness of regulatory legislation, guidance and practice, ICH/GCP and relevant Sponsor requirements.
- Complete submissions to and liaise with IRB/IEC/Third body/Regulatory Authority as applicable regarding submission/approval issues.
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
- Perform a review of final submission documents as applicable.
- Ensure appropriate systems are updated accurately and compliantly, ensuring others follow established processes.
- Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required.
- Mentor and coach other Site Readiness and Regulatory Operations team members.
- ** In-Country specific tasks (Global)**:
- Serve as primary contact for investigative sites and ensure documents required are collected...
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