Medical Writer

Veeda CR; Ahmedabad District; On-site; INR 1,000,000 - 1,400,000; Full time

Job summary

Veeda CR is seeking a capable Clinical Operations professional to prepare and review protocols, ICDs, synopsis and other study documents, including Investigator Brochure, for regulatory submissions and audits.

The role covers feasibility evaluation, literature searches, protocol training, CSR preparation, CTD/eCTD compliance, and archival of reports with the Clinical Operations team. It also involves SOP development and process improvements within the department.

Responsibilities

• Preparation & Review of Protocol, ICD, Synopsis and other study specific documents e.g. patient diary card.
• Preparation & Review of Investigator Brochure.
• Evaluating trial feasibility (preliminary and detailed) for patient based clinical studies along with medical team for various regulatory submissions.
• To support in reference literature search as required for assigned projects.
• Providing the Protocol Training to Monitors and site team if required.
• Preparation & Review of Clinical study report (CSRs) for phase trials conducted by Clinical Operations Department of Veeda as per regulatory requirement and define timeline in project grid - Study execution sheet in coordination with the Project Manager.
• Preparation & Review of Full CSRs, Abbreviated CSR, Synoptic CSR, Shell and Interim report as per Sponsor necessity.
• Preparation & Review of Full CSRs, Abbreviated CSR, Synoptic CSR, Shell and Interim report as per Sponsor necessity.d as part of CTD/eCTD as per applicable regulatory requirements.
• Review of statistical analysis plans, mock shells and table/figure/listing specifications for appropriate content.
• Perform literature searches/reviews as necessary to obtain background information and development of documents.
• Compliance to sponsor audit and regulatory inspections (e.g., USFDA, EMA, DCGI etc.) and query/deficiencies reply.
• To ensure and improve quality & presentation of report through writing, editing and/or managing the production of high‑quality clinical documentation (e.g., Study Report, Summary Documents and ensure compliance of documentation to internal company standards and external regulatory guidelines).
• Preparation and review of departmental SOP and other departmental SOPs as required.
• Ensure that the reports and appendices and related material are archived / e‑archived in a timely manner.
• Preparation of project summary and submit to reporting head/designee (If required)
• Develop and maintain the necessary templates, formats and styles to ensure that documents generated meet the industry, internal, client & regulatory requirements.
• Participate in departmental or interdepartmental process improvement and training initiatives.
• Perform any other duties as assigned by Department Head.

Job description

Primary Responsibility

1. 1. Preparation & Review of Protocol, ICD, Synopsis and other study specific documents e.g. patient diary card.
2. 2. Preparation & Review of Investigator Brochure.
3. 3. Evaluating trial feasibility (preliminary and detailed) for patient based clinical studies along with medical team for various regulatory submissions.
4. 4. To support in reference literature search as required for assigned projects.
5. 5. Providing the Protocol Training to Monitors and site team if required.
6. 6. Preparation & Review of Clinical study report (CSRs) for phase trials conducted by Clinical Operations Department of Veeda as per regulatory requirement and define timeline in project grid - Study execution sheet in coordination with the Project Manager.
7. 7. Preparation & Review of Full CSRs, Abbreviated CSR, Synoptic CSR, Shell and Interim report as per Sponsor necessity.
8. 7. Preparation & Review of Full CSRs, Abbreviated CSR, Synoptic CSR, Shell and Interim report as per Sponsor necessity.d as part of CTD/eCTD as per applicable regulatory requirements.
9. 9. Review of statistical analysis plans, mock shells and table/figure/listing specifications for appropriate content.
10. 10. Perform literature searches/reviews as necessary to obtain background information and development of documents.
11. 11. Compliance to sponsor audit and regulatory inspections (e.g., USFDA, EMA, DCGI etc.) and query/deficiencies reply.
12. 12. To ensure and improve quality & presentation of report through writing, editing and/or managing the production of high‑quality clinical documentation (e.g., Study Report, Summary Documents and ensure compliance of documentation to internal company standards and external regulatory guidelines).
13. 13. Preparation and review of departmental SOP and other departmental SOPs as required.
14. 14. Ensure that the reports and appendices and related material are archived / e‑archived in a timely manner.
15. 15. Preparation of project summary and submit to reporting head/designee (If required)
16. 16. Develop and maintain the necessary templates, formats and styles to ensure that documents generated meet the industry, internal, client & regulatory requirements.
17. 17. Participate in departmental or interdepartmental process improvement and training initiatives.
18. 18. Perform any other duties as assigned by Department Head.