Senior Associate - Medical Writing | Q892

Senior Associate - Medical Writing | Q892

06 Jun
|
Silmed Scientific Pvt Ltd
|
Bangalore Urban

06 Jun

Silmed Scientific Pvt Ltd

Bangalore Urban

Job Profile

We are hiring an experienced medical writer with experience in CTD medical writing and experience in clinical development of medicines.



Writing high quality CTD modules nonclinical and clinical overviews & summaries (Module 2.5, 2.4, 2.7, 2.7) as per requirements in EU submission



Response to clinical deficiencies



Assist with drug development strategy



SmPC, Patient information leaflet



Clinical study reports, Study design and synopsis



Assist in clinical development strategy Review of Study reports published papers



Literature search and regulatory evaluation



Rx to OTC evaluation



PSURs, PADER, RMP



Ideal candidate should have





Must have 4-7 years previous experience authoring global clinical submissions including, but not limited to, clinical study reports (CSRs), study protocols, informed consent forms (ICFs), protocol amendments, ICF amendments, eCTD modules specifically 2.4 - 2.7), DSURS, PBRERs and signal evaluation reports. Working knowledge of industry guidelines and standards (FDA, EMA, ICH, PMDA)



Scientific accuracy



Attention to details



Understanding of Generic, Hybrid and New drug applications



Experience in Clinical study design and protocol



Excellent communication skills and time management



Experience in Clinical and non-clinical overviews is a must

The original job offer can be found in Kit Job:
https://www.kitjob.in/job/22923439/senior-associate-medical-writing-q892-bangalore-urban/?utm_source=html

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