Synergen Bio Hiring For Project Management And Biopharmaceutics Dept
Position: Sr. Manager
Department: Project Management and Biopharmaceutics
Qualification: B. Pharm, M.Pharm, Msc
Experience: 10+ year's
No Vacancy: 01
Note: Immediate joiner preferred
Job Location: Shivajinagar, Wakadewadi Pune.
Tasks Responsibilities:
•Lead the Bio- PK team to plan and execute BA/BE studies for various regulatory markets.
•Manage the designing of PK studies for demonstrating bioequivalence (BE) for solid,
•liquid, topical and specialized dosage forms including parental. Extensive literature search, medical narrative writing and summary report writing.
•Coordinate with all Cross functional team for support and development of Clinical
•Research Project. Review and evaluation of pilot bio-study clearance report and results before initiation of the pivotal bio studies to attain pivotal bio-success.
•Develop, review and recommend scientifically support PK study BE protocols for ANDAS
•Review of Bioequivalence study protocols prepared within team and ensuring its completeness with respect to scientific and regulatory requirements.
•Review draft and final BE study report and ensure its correctness as per applicable regulatory requirements.
•Responsible for overall conduct and management of medical writing activities.
•Responsible to providing support to clients with regards to CRO services
•Proactively identify the risk in ongoing studies and ensure the problem is fixed up in consultation with respective department and sponsor.
•Preparation of service agreement and other confidential documents.
•Ensuring logistic support from sponsor.
•Ensure the submission of DCGI NOC documents to the office of DCGI for BA/BE studies for requisite approval on time.
•Projects Slotting. Coordination with Clinical operation and screening team for slotting of Projects.
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