Medical Writing
Bluemotion Enclave
Work from Office
Full Time
Min. 3 yearsJob Description
Medical Writing
Job Description
Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas.
1. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules.
2. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required.
3. To work in coordination with all the members in the study team- internal and external for the development of clinical documents.
4. Share project timelines amongst the study team for the development of document.
5. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document.
6. Review statistical analysis plans and table/figure/listing, when required.
7. Ensure uniformity and consistency in the scientific content of the regulatory document
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