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Regulatory Associate - Medical Writing Silmed Scientific

3.0 - 7.0 years

0 Lacs

kochi, kerala

On-site

As an experienced medical writer with expertise in CTD medical writing and clinical development of medicines, your responsibilities will include the following: Writing high-quality CTD modules such as nonclinical and clinical overviews & summaries (Module 2.5, 2.4, 2.7, 2.7) to meet EU submission requirements. Addressing clinical deficiencies by providing appropriate responses. Contributing to drug development strategy. Updating documents like SmPC, Patient Information Leaflet, CCDS, Safety variations. Preparing Clinical Study Reports, Study design, and synopsis. Assisting in the formulation of clinical development strategies and reviewing study reports and published papers. Conducting liter...

Posted 3 months ago

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