Sonali J.
Medical Writer i @Syncorp Health Pvt Ltd
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WORK HISTORY
Medical Writer i @Syncorp Health Pvt Ltd
Bengaluru, IN
EDUCATION
Swami Ramananad teerth marathwada university Nanded
M pharmacy, Quality Assurance
ABOUT SONALI J.
Medical Writer l at Syncorp Health Pvt. Ltd, Bangalore. 2 yrs 5 months experience. Job Description: Authoring clinical documents that are part of regulatory submission including Protocol, Investigator Brochure (IB), Informed consent documents (ICD), Clinical study report (CSR) across the various therapeutic areas. Preparation / Review of Clinical Study Reports within proposed timeline according to the raw data ad as per the regulatory requirements. Clinical trial registration on CTRI. Coordination with clinical, analytical departments and principal and co-investigators while preparation of clinical study reports and compilation of various data. CS-BE Tables and other supplementary documents as per the regulatory requirement. Preparation of eCTD module 5, module 2.7 tabular listing and related documentation for obtaining marketing authorization of pharmaceuticals in European Union (EU), USFDA and Canada. Compliance checking, linking, bookmarking, review of documents, creation of external links in eCTD format. Preparation and Review of inhouse Standard Operating Procedure (SOP). Summary Report writing. Preparation of DBE summary tables. Preparation of Clinical Study Updates and inform to the sponsor and Ethics committee. Coordination with the Ethics committee in submission of study related documents and obtaining approvals. Check IEC approval documents and submit to QA. Compilation of CRFs and raw data. Co-ordinating with project management team to complete the project in given timeline. Reviewing draft and final clinical study report and ensuring its correctness as per applicable regulatory requirements. Clinical Data Interchange Standard Consortium (CDISC) data entry.
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