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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Recruitment Services |
| Functional Area | Technical Writing |
| EmploymentType | Full-time |
Author , quality check and review of documents such as , but not limited to , Protocol , ICF , PIS , Study Reference Manual , CSR , Safety Reports , ITU Summaries , RAMPCT , CSS , CSE and CTD Modules , etc. Work closely with the study team , particularly with investigators and develop/author specific clinical documents. Drafting , ensuring client review , addressing internal and client review comments; client interactions , appropriate follow- up with all stakeholders to ensure timely submission. Quality check of above- mentioned documents and other regulatory documents (clinical study reports , study protocols , protocol amendments , IB , etc.) , whenever required. Ensure deliverables are completed as per the agreed timelines and meet required quality standards Timely escalation of identified unresolved issues to supervisor Mentoring other writers Experience & Skills Required: Minimum 4 years of Regulatory Medical Writing experience in authoring Protocol , ICF documents , safety reports , Ethics submissions , familiarity with Integrated Research Application System (IRAS). Have good understanding of early phase clinical trials Excellent written and verbal communication skills , interpersonal skills,
Keyskills :
clinicaltrials safety protocols research literature qualitycheck studyreports medicalwriting qualitystandards communicationskills interpersonalskills verbalcommunication summarizinginformation ib bpo csr css cse ctd tatementsofworksow