Veeda Clinical Research hiring Clinical Study Report Writer – Late Phase Trials

Veeda Clinical Research hiring Clinical Study Report Writer – Late Phase Trials

27 April, 2022

*Urgent Hiring*

We at Veeda Clinical Research hiring for below mentioned position.

Position: Clinical Study Report Writer – Late Phase Trials

Experience: 2 – 4 years

Location: Ahmedabad

Job Responsibilities:

1.Clinical study report (CSRs) preparation of late phase trials as per regulatory requirement and define timeline in project grid – Study execution sheet in coordination with the Project Manager.

2.Preparation of Full CSRs, Abbreviated CSR, Synoptic CSR, Shell and Interim report as per Sponsor necessity.

3. Preparation and finalization of clinical study report and related appendices/documents for adequacy to be submitted as part of CTD/eCTD as per applicable regulatory requirements.

4. Review statistical analysis plans, mock shells and table/figure/listing specifications for appropriate content.

5.Perform literature searches/reviews as necessary to obtain background information and development of documents.

6.Compliance to sponsor audit and regulatory inspections (e.g. USFDA, EMA, Canada, ANVISA, DCGI, TGA, NMPA, China, etc.) and query/deficiencies reply.

7. 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).

8.Preparation and review of SOP and other departmental SOPs as required.

9.Ensure that the reports and appendices and related material are archived / e-archived in a timely manner.

10.Preparation of project summary and submit to reporting head/designee.

11.Develop and maintain necessary templates, formats and styles to ensure that documents generated meet industry, internal and client requirements.

12.Participate in departmental or interdepartmental process improvement and training initiatives.

13.Perform any other duties as assigned by reporting head.

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