Job Overview
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Date PostedOctober 14, 2022
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Location (State / UT)
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Expiration date--
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Experience1 Year, 6 Years
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GenderAny
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Desired QualificationMaster’s Degree
Job Description
Clinical Research – Biopharmaceutics
Roles and Responsibilities:
. Feasibility assessment/ new product evaluation
• Literature review and BA/BE study designing
• BE Study Monitoring
• Preparation of documents for regulatory submission (i.e BENOC, Import license application, etc.)
• Establishment and maintenance of study documents
• Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summary tables, etc.)
• Review of BE study documents i.e protocol, reports, ICF, etc.
• Preparation/review of medical write up
• Coordination for serious adverse event reporting and safety updates to Regulatory agency
Desired Candidate Profile
M. Pharm (Pharmacology) with 2-5 years of Relevant Experience