Medical Officer

The Best Services & Enterprise's

Clinical Development:

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, . 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

No. of Openings : 04

Education : MBBS, M.Pharma, Ph.D/Doctorate, MPHIL

Role : Medical Officer

Industry Type : Hospitals / Medical / Healthcare Equipments

Gender : [ Male / Female ]

Job Country : India