Executive - Project & Engineering
Amneal Pharmaceuticals
Date: 10 hours ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Description
Clinical BE Strategy of New added Product
BE strategy finalization based on feasibility assessment across all CRO’s and literature review.
Discussion and update to R&D for the BE strategy of newly added products.
CRO Selection for biostudies
Based on prior studies experience, quality, and regulatory track record and quotations.
DCGI NOC related Coordination
Coordination with R&D team to get COA, CPS and stability data.
Coordination with CRO for submission of application for DCGI approval.
To resolve the DCGI application queries raised by CRO and /or CDSCO.
Bioequivalence Studies Project Management
CoOrdination between Sponsor & CRO
Ensure DCGI approval in place prior to study start.
Coordination with R&D for the IPs shipment to CRO.
Coordination for the IPs related queries and responses.
Study planning and execution based on product readiness.
Tracking of major milestones of the study activities like completion dosing, completion of bioanalysis of samples, final results and final report timelines.
Coordination for the sample shipment in case of analysis outside of India and other site for Bioanalytical activities.
Coordination for IMP shipment back to F&D for specific dosage forms like inhalation, TDS etc..
Coordination for the availability of final BE report from CRO for RA submission.
Financial Management of all the studies.
Quotation negotiation and finalization in consultation with dept. head.
Overview of the study invoices and related payments.
Contracts review and finalization with CROs.
Invoice processing
Biopharmaceutics Data review (Pharmacokinetic data analysis)
PK Study results review and discussion across the internal team.
PK Study results update and discussion with R&D.
Strategy update based on result review
Clinical strategy update based on study results review.
Update to R&D of the new clinical strategy.
Any other work assigned by the Dept. head as per the requirements
Qualifications
B.E / M.E/ B.Tech /M.Tech
Clinical BE Strategy of New added Product
BE strategy finalization based on feasibility assessment across all CRO’s and literature review.
Discussion and update to R&D for the BE strategy of newly added products.
CRO Selection for biostudies
Based on prior studies experience, quality, and regulatory track record and quotations.
DCGI NOC related Coordination
Coordination with R&D team to get COA, CPS and stability data.
Coordination with CRO for submission of application for DCGI approval.
To resolve the DCGI application queries raised by CRO and /or CDSCO.
Bioequivalence Studies Project Management
CoOrdination between Sponsor & CRO
Ensure DCGI approval in place prior to study start.
Coordination with R&D for the IPs shipment to CRO.
Coordination for the IPs related queries and responses.
Study planning and execution based on product readiness.
Tracking of major milestones of the study activities like completion dosing, completion of bioanalysis of samples, final results and final report timelines.
Coordination for the sample shipment in case of analysis outside of India and other site for Bioanalytical activities.
Coordination for IMP shipment back to F&D for specific dosage forms like inhalation, TDS etc..
Coordination for the availability of final BE report from CRO for RA submission.
Financial Management of all the studies.
Quotation negotiation and finalization in consultation with dept. head.
Overview of the study invoices and related payments.
Contracts review and finalization with CROs.
Invoice processing
Biopharmaceutics Data review (Pharmacokinetic data analysis)
PK Study results review and discussion across the internal team.
PK Study results update and discussion with R&D.
Strategy update based on result review
Clinical strategy update based on study results review.
Update to R&D of the new clinical strategy.
Any other work assigned by the Dept. head as per the requirements
Qualifications
B.E / M.E/ B.Tech /M.Tech
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