Assistant Manager - Medical Writing
Current- Preparation, finalization, and review of clinical study documents (protocol and amendments, synopsis, case report form (CRF), informed consent document (ICD), clinical study report (CSR)- Submission of clinical study documents to IEC/IRB- Preparation, finalization, and review of medical writing related SOPs/WIs, template for clinical study documents (protocol, ICD, CRF, and CSR)- Preparation for project updates, audit, and inspection- eCRF creation using in-house CRF portal and Study Data Tabulation Model related activities- Quality check of PDF specifications for submission documents.- Meeting timelines, handling documents by proper filing and archival of documents as required.- Handling queries from management/ Regulatory authorities/ Sponsors.- Collecting literature references