Executive Search Specialist at HR Cornucopia Pvt Ltd.
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Head - Clinical Operations (14-20 yrs)
1. Literature review for preparation of BA/BE protocol & Dissolution strategy note
2. CRO identification and qualification for Biostudy execution
3. Preparation, review & approval of the pilot and pivotal BA/BE study protocols for various regulatory market
4. Review of BE approach document, Preparation and review of Dissolution strategy note. Review & approval of BENoC & BETL related documents
5. To plan and execute pilot & pivotal bio studies for various regulatory markets in approved CRO's to facilitate due date filing
6. Identify bio relevant media, review of invitro & invivo data and interpretation of pilot BE study results to provide technical support to formulation team for enhancing the bio success rate.
7. Updating quality system requirements through auditing & continuous monitoring during bio study execution for targeted CRO's to meet the regulatory requirements
8. Pilot and pivotal bio study report review to facilitate the due date filing
9. To handle biostudy related regulatory queries efficiently and plays vital role in obtaining final approval to facilitate successful launch in market
10. Nonclinical and Clinical dossier documents preparation and review to facilitate due date filing
11. Budget planning / cost negotiation for BA/BE studies
12. Logistics management of products, samples and documents etc
13. Second line creation for protocol preparation, bio study report review and bio study monitoring through coaching and continuous training.
14. Prepare & implementation of new SOP's & templates to create robust system
15. Experience in Pre-IND, Pediatric Investigation Plan Application and Pre-NDA meeting document preparations and review will be added advantage.
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