Reviewing of preclinical studies as per the regulatory requirements to support the clinical bridging.
Data search/retrieval from the literatures and other publicly available sources for clinical and non-clinical queries and other medical deliverables.
Review of preclinical study reports.
Designing of protocols for clinical studies(Phase I-Phase IV) for various regulatory submissions.
Preparation and review of clinical overview (CO) & Non-clinical overview (NCO) for regulatory submissions.
Preparation/review of regulatory submission documents like Scientific advice, Pre-IND package, controlled correspondence and Initial paediatric study plans etc.
Supporting to clinical research aspects of products in development and supporting to other miscellaneous activities where medical reviewer intervention is needed.
Providing the inputs for SOPs as per regulatory requirements and ICH-GCP to harmonize the activities.
Qualification & Experience
MBBS/M.Pharm (Pharmacology)/Phd/BDS/PharmD
5 to 10 years of experience
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