Regulatory Associate - Medical Writing Silmed Scientific

3.0 - 7.0 years

0 Lacs

kochi, kerala

On-site

As an experienced medical writer, your role will involve writing high-quality CTD modules including nonclinical and clinical overviews & summaries such as Module 2.5, 2.4, 2.7 as per the EU submission requirements. You will also be responsible for responding to clinical deficiencies, assisting in drug development strategy, updating SmPC, Patient information leaflet, CCDS, Safety variations, preparing clinical study reports, study design, and synopsis. Additionally, you will play a key role in the clinical development strategy, review of study reports, published papers, literature search, and regulatory evaluation. Your expertise will be crucial in Rx to OTC evaluation, PSURs, PADER, and RMP....

Posted 3 weeks ago

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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 4 months ago

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