Job Description
1.Responsible for authoring regulatory/ safety documents such as Protocol, CSR,PBRER/PSUR, Subject Narratives, Aggregate Reports, RMPs and others
2.Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations
3.Ensure that clinical documents adhere to current global standards, FDA, ICH and GCP guidelines and are in accordance with electronic publishing standards. Update SOPs and other job aids for completeness as needed
2.Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations
3.Ensure that clinical documents adhere to current global standards, FDA, ICH and GCP guidelines and are in accordance with electronic publishing standards. Update SOPs and other job aids for completeness as needed
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