- Full time
- Part time
- One time
• In-depth knowledge of the methods and principles of clinical practices of Bioequivalence and Bioavailability Studies.
• ICH-GCP and Regulatory activities.
• Possess excellent project management, coordination, communication and organizational skills.
• Preparation and submission of various applications required for BA/ BE studies to CDSCO.
• Experience of Compilation & Submission including Bookmarking & Hyper linking of Clinical Study Reports as per requirement of different regulatory bodies in various formats like Module-5 Electronic Common Technical Document (eCTD) as per ICH- E3 for US FDA, NeeS for EMEA & MHRA etc.
• Performs publishing and quality control tasks on submission components.
• Experience of Software tool like PharmaReady eCTD Version 5.1, LORENZ docuBridge®, LORENZ eValidator™, Adobe Pro Extended Version 9.0 for report publishing for different regulatory bodies.
Research Associate- I
Synapse Labs Pvt. Ltd
From December 2010
• To plan, monitor and control various phases of different project.
• To plan the project to be conducted at various departments.
• To update the management regarding the progress of various project activities.
• To communicate with the clients in written as well as oral form.
• To act as a point of communication between with the Project Personnel and the Sponsor in order resolve queries (if any) related to project activities.
• To allot the Project Number to the upcoming new projects to be conducted at the facility.
• To prepare service estimates and service agreement for different projects.
• To prepare Confidentiality Agreements, Non-circumvention Agreements and other Agreements as required.
• Compilation of final Clinical Study Report and sharing the same with Sponsor.
• Communication with regulatory authorities for study related regulatory approval and related queries.
Microbiologist (Quality Control)
December 2009 - May 2010
Media Preparation, Environmental monitoring, Sterility tests.
Qualifications & Certifications
Clinical Research and Clinical Data Management
Pravara Institute of Medical Sciences
M.S.G College Malegaon, Nashik
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