MSN Laboratories Pvt Ltd Job Vacancy For M.Pharm
Urgent Requirement for clinical research (CPPK FR&D) Department -MSN R&D Centre, Pashamylaram.
Experience: 3 to 6 years
Positions: Executive / Senior Executive
Qualification: M. Pharma Pharmacology Collection and review of Literature from different regulatory sites, these include EUSmPC, US FDA-Label, Canada-Product monograph, New Zealand -Datasheet (MEDSAFE) etc., for preparation of protocols for Phase-I and BA/BE studies.
Clinical trial related documentation (Site documents, filing, CRF preparation)
Protocol preparation and review for ANDA and Clinical studies submission
Monitoring of bio studies, Site initiation visits, Closeout visits for studies out sourced to various CRO's as per ICH-GCP and SOPs.
Experience in Planning, Risk & Issues, Change Management,Dependency management, MI Reporting, Project Budgeting &Cost Control and supporting Project managers.
Different regulatory Filing queries handing (USFDA, CDSCS & EMEA)
An active role in the preparation of Investigator's brochure for all the dosage forms as per ICH-GCP. Reviewing of Pre-clinical protocols and study related documents with respect to the regulatory requirements and portfolio requirements.
Active participation and evaluation of trial related costing for the molecules by supporting business team portfolio.
Supporting other stake holders (Viz., Regulatory) regarding submission of clinical studies for different regulatories. Analysis of Pharmacokinetic data (Phoenix WinNonlin Software
Tracking of all study related DCGI documents (Viz., NOC, Permissions and covering letters) regardless of the molecule to streamline the smooth execution of BE studies. Triggering criticalities in bioanalytical aspects of a protocol per the regulatory requirements.
Mail id: simhachalam.piniminti@msnlabs.com
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