Study Director - General Toxicology Aurigene Pharmaceutical Services Limited

5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

The role involves serving as the single point of scientific, administrative, and regulatory control for the study. You will actively participate and supervise all study activities, including animal dosing, clinical signs observation, data collection, and analysis, ensuring compliance with relevant regulations, OECD Principles of GLP, and SOPs. Additionally, you will be responsible for the operation, maintenance, and proper utilization of various equipment/instruments like centrifuges, laminar air flow systems, anesthetic machines, and syringe pumps. Your duties will also include the preparation and updating of SOPs relevant to in vivo and in vitro experiments. Moreover, you will be expected to effectively communicate important information to key study personnel, the sponsor, and other relevant scientists. You will have the authority to approve amendments and deviations to the study plan and must respond to QA findings promptly, ensuring their resolution in a timely manner. As part of this role, you will be responsible for approving study plans, amendments, and reports, as well as ensuring the timely archiving of the study in accordance with existing practices. You will also have all the responsibilities of a Study Director as outlined in the applicable SOPs.,

Posted 3 days ago

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