Experience

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  Cbcc-vibgyor research pvt. ltd.

  Aug 2008 - Sept 2009

  Clinical research coordinator - facilitating medical innovation and breakthroughs

  - Managed multiple Phase III RCTs of breakthrough innovative medicines and devices in cardio-vascular disorders

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  Nirma university

  Sept 2009 - Feb 2010

  Assistant professor of pharmacy - empowering minds

  - Designed a B.Pharm honors 5-year integrated/add-on course- Helped 280 students to graduate with this add-on course and made them eligible for registered pharmacist in USA

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  Zydus group

  Jan 2010 - Jul 2013

  Senior lead spearheading pkpd and babe studies

  •Bioequivalence study protocol preparations, review and finalization. In this area the key strengths includes assessment of the pharmacokinetic profile of the molecule and to decide about design of Bioequivalence study protocol•Manage outsourcing of Bio availability/Bioequivalence and clinical studies for generic dossier submissions.•Manage pharmacokinetic data analysis and designing protocols for EU, USFDA, MCC, ANVISA, Thai DA, PMDA and COFEPRIS studies. • Review of study reports to find out inadequacy in study design/bio analytical methods=.•Preparation of pharmacokinetic queries, critical scientific justification and submissions to FDA/EMEA/ANVISA for opinion or approvals.•Performed statistical calculation on the in-vivo data using WINNONLIN software to calculate the in-vivo parameters to conclude on the bioequivalence outcome, extrapolate the data for finding adequate subject number for pivotal study.•To investigate any bio-equivalence failure and to understand the reason of failure and then to provide opinion on dissolution behavior and targeted dissolution profile/media so as to achieve a successful bio-equivalence study.•Identification of bio relevant in vitro dissolution media and test conditions (after analyzing the physico-chemical and bio-pharmaceutical property of the drug molecule) and supporting the FR&D team in development/optimization of a bioequivalent product•Evaluation of the in vitro dissolution data to look for the similarity of the drug products as per the rate and extent of release and resolve any variability if at all associated with the dissolution profile.•Utilization of In vitro In vivo correlation (IVIVC) and/or In vitro In vivo relation (IVIVR) to understand the dissolution profile wherever possible, especially in case of modified and delayed release drug products for formulation development Show less

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  Novartis

  Aug 2013 - May 2022

  Thorough understanding and adherence of processes for publication and medical education deliverables and hands-on-experience of all kinds of deliverables including key and complex publication deliverables • Performs quality control (QC) checking / proof reading of documents to meet customer expectation• Demonstrate leadership team by proactively participating in the team initiatives and representing OSW team at various platforms at site level events and before leadership team• Builds working relationships and actively collaborates with key internal and external stakeholders to achieve high quality outputs not as an individual but also as a team player• Proven ability for enhancing language, punctuations, and readability and content flow of the scientific documents with thorough scientific understanding• Complies with and support OSW group’s project management tool, standards, policies and initiatives • Follows Novartis specifications for documentation, specifically Novstyle, templates etc • Follows and tracks clinical trial milestones for assigned projects• Maintains records for all assigned projects including Datavision and other databases, audit, SOP and training compliance• Participate in international congresses and conferences; development of pre and post congress scientific communication deliverables• Participate in the development of strategic deliverables• Implementing Lean Six Sigma methodology in various projects and process Show less

  • Transformative Operations Strategist: Orchestrating Efficiency and Growth Initiatives

    Nov 2019 - May 2022

  • Principal content developer - Elevating research through persuasive communication

    Aug 2013 - Nov 2019
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  Innomagine pharma consulting

  May 2022 - now

  Transforming business: leading innovation, operations, and strategy