Dhaivat Joshi

Experience

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  Alembic Pharmaceuticals Limited

  Jun 2015 - Aug 2016

  Regulatory Affairs Associate

  -Conducted routine and spot inspections of materials, machinery, and production lines. Thoroughgoing knowledge of Drug Development Process. -Analyzed test results and drafted reports detailing findings. Updated logs and compiled reports consistently to facilitate comprehensive information for review. Investigated and controlled cGMP forms.-Reviewed, documented and reported deficiencies to management, maintained working relationship with regulatory authorities generated reports and identified opportunities for process improvement. Show less

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  MCPHS University

  Oct 2016 - Dec 2018

  -Developed and designed multiple projects for creating disease specific evidence and analyzed results for oncology and neurological disorders. -Provided research support by tracking and reviewing data using ClinPlus EDC; Assisted research lead through communicating, reporting and analyzing data using various analytics tools.-Assisted research lead for conducting clinical trials and evaluated multiple outcomes. Outlined Data Management Plan from concept to completion. Thoroughgoing knowledge of GCP and ICH principles, understanding of CRFs review. Show less

  • International Brain Cell

    Sept 2017 - Dec 2018

  • Research Assistant

    Oct 2016 - Jun 2018
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  Tufts Medical Center

  Jun 2018 - Aug 2018

  Center for Evaluation of Value and Risk in Health (CEVR) Intern

  -Investigated analytical and fact-finding work from multiple databases in support of concept development.-Provided healthcare data in support of evidence and value development and developed economic models for successful implementation of strategic population health initiatives.-Executed, reviewed and approved cost-effective analysis of more than 400 studies in the development of evidence-based practices for public health and clinical programs. -Reviewed, analyzed and approved cost-effective studies based on ICD 10 classification to Tufts database. Show less

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  Sanofi Genzyme

  May 2019 - Feb 2022

  -Provided evidence and value development for orphan drugs and rare diseases within R&D function.-Planned, designed, implemented, and completed evidence generation that were consistent with product strategies by working closely and parallel with clinical development (natural history studies, PROs, economic models, budget impact, clinical outcome generation, CVD, AMCP, retrospective chart reviews, real world evidence, systematic literature reviews, patient/caregiver interviews) to achieve value propositions.-Worked closely with market access team and supported pricing and commercialization efforts.-Established KOL relations, managed advisory boards and HE boards, including managing relationships with patient associations. -Contributed to scientific communication, representation at professional associations, HE and medical conferences.-Managed vendor relations, RFPs, data collection, on-time finalization of projects, and evidence generation including publications. Show less

  • Contracts Manager: HEVA Rare Blood and Rare Disease

    Jan 2021 - Feb 2022

  • Research Associate HEOR

    May 2019 - Jan 2021
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  TFS HealthScience - Contract Research Organization

  Feb 2022 - now

  Business And Contracts Manager