Mumbai, Navi Mumbai
manages Study Operational Plan and Cro Activities, Including Project Timelines & Quality of Deliverables Throughout the Life of the Assigned Clinical Trial(s)
reviews and Refines Clinical Operational Plans Including the Study Monitoring At Cro Site for all Be Studies
maintains Frequent and Meaningful Contact with Cros to Assess Performance and Provide Guidance as Needed.
oversees Clinical Trial Sites Adherence to Pertinent Regulations Through Review of Monitoring Reports, Cqa-gcp Audit Report, Communications with Investigators, Study Site Personnel, Cras, and other Cro/designee Personnel
work Closely with other Teams in the Organization, E.g. Quality, Regulatory, Etc
new Product Identification:
suggestion of New Product Ideas for Domestic Markets as Well as International Markets
evaluation of In-licensing Opportunities, Participate in Due-diligence from Medical Perspective.
evaluating New and Unique Drug Formulations with Novel Drug Delivery System
to Represent Company At Dcgi Office for New Drug / Fixed Dose Combination Approvals.
to Effectively Assist in all Regulatory Activities Including Dcgi Dossier Preparation, Ctd Review.
ensure Data Accuracy, Clinically Valid Case Assessment, Regulatory Reporting Status Assessment, and Follow-up On Pharmaco-vigilance Cases.
preparation/review of Scientific Product Rationales for Submission to Regulatory Authorities.
|Experience||5 - 10 Years|
|Salary||7 Lac To 11 Lac P.A.|
|Industry||Pharma / R&D / Biotech|
|Qualification||MBBS, M.Pharma, Ph.D/Doctorate, MPHIL|
|Key Skills||Medical Officer Drug Regulatory Pharmacy|
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