Umesh Chaudhary
Morrisville,USA
Summary
Experienced healthcare leader with over 20 years in pharmacy practice and healthcare management. Specializes in clinical research, regulatory compliance, and process improvement. Skilled at leading cross-functional teams, optimizing workflows, and driving data-driven solutions. Holds certifications in Lean Six Sigma, Agile Project Management, Clinical Trials Operations, Pharmacovigilance, and Good Clinical Practice (GCP), ensuring regulatory adherence and improving patient care outcomes. Passionate about enhancing healthcare delivery through innovative, patient-centered approaches. Seeking to leverage expertise in clinical research to contribute to the success of clinical trials and advance into project management roles.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Clinical Pharmacist
Advance Community Health
02.2024 - 12.2024
- Led regulatory compliance for the 340B Drug Pricing Program, ensuring adherence to HRSA standards and successful audit outcomes.
- Designed and implemented a GPT-powered tool to enhance the efficiency of prescribing hormonal contraceptives for patients.
- Managed chronic disease programs, including Medication Therapy Management (MTM), diabetes care, and infectious disease management, improving patient outcomes.
- Applied Lean Six Sigma principles to streamline pharmacy workflows, reducing inefficiencies and optimizing team productivity.
- Utilized EPIC EHR to enhance clinical documentation, support interdisciplinary collaboration, and streamline patient care processes.
- Implemented fraud, waste, and abuse prevention measures in pharmacy operations, leading to significant cost savings and operational improvements.
- Collaborated with healthcare teams to manage complex patient cases, optimizing medication therapies and improving health outcomes.
Pharmacy Director & Co-Founder
Youngsville Pharmacy
05.2019 - 12.2024
- Led daily pharmacy operations, ensuring regulatory compliance, inventory control, and optimal prescription dispensing to meet clinical and business objectives.
- Supervised and trained a high-performing team, implementing performance goals and operational improvements to drive efficiency and productivity.
- Utilized project management skills to streamline pharmacy workflows, reduce medication errors, and optimize medication stock levels.
- Collaborated with healthcare providers to enhance medication therapy management, improving patient outcomes and ensuring safe medication use.
- Managed the pharmacy budget, integrating cost-saving measures without compromising patient care or service quality.
- Conducted internal audits and quality assurance checks to ensure regulatory adherence and maintain high standards of patient care.
- Integrated emerging pharmacy technologies to improve operational processes, enhance data accuracy, and facilitate interdisciplinary collaboration.
Clinical Pharmacist
Piedmont Health Services Inc
05.2015 - 01.2019
- Managed chronic disease programs, including diabetes, hypertension, and anticoagulation therapy, improving patient care and health outcomes.
- Provided medication therapy management (MTM), collaborating with healthcare teams to optimize treatment plans and ensure medication safety.
- Educated patients and healthcare providers on medication usage, side effects, and lifestyle management, promoting improved adherence and health outcomes.
- Ensured compliance with regulatory standards (JCAHO, 340B, DEA, FDA) while maintaining patient safety and high-quality care.
- Conducted clinical reviews, including lab assessments and medication reconciliations, to identify potential drug interactions and optimize therapies.
- Participated in quality improvement initiatives, leveraging clinical data to enhance care delivery and minimize patient risks.
- Analyzed trends in medication use and made recommendations for policy updates.
- Streamlined medication reconciliation process, reducing medication errors and enhancing patient safety.
Pharmacist & Pharmacy Manager
Wal-Mart Stores
01.2010 - 06.2015
- Managed daily pharmacy operations across multiple locations, optimizing workflows to ensure compliance with regulatory standards and enhance patient safety.
- Led a team of 12 pharmacy staff, setting performance goals and implementing operational strategies to improve efficiency and service delivery.
- Spearheaded inventory management projects, reducing medication discrepancies and waste while maintaining optimal stock levels to meet patient needs.
- Collaborated with healthcare providers to streamline medication therapy management processes, improving treatment adherence and patient outcomes.
- Directed the implementation of error-reduction strategies in prescription filling processes, significantly minimizing medication errors and ensuring patient safety.
- Led project initiatives to enhance patient safety protocols, including medication reconciliation and risk assessments, ensuring quality care delivery.
- Managed operational budgets, focusing on cost control without compromising patient safety or the quality of pharmaceutical services.
- Conducted comprehensive staff training on safety practices, medication handling, and regulatory compliance to maintain high standards of care.
Impatient Clinical Pharmacist
Riverview Hospital
01.2009 - 12.2009
- Collaborated with healthcare teams to optimize medication therapy in the inpatient setting, focusing on patient safety and treatment efficacy.
- Managed chemotherapy medication preparation, ensuring accurate dosing and safety in accordance with oncology protocols.
- Conducted medication order reviews and provided recommendations to improve therapeutic outcomes and minimize adverse drug reactions.
- Participated in quality improvement initiatives, contributing to the enhancement of medication safety protocols and patient care standards.
Pharmacy Manager
TARGET Stores
01.2008 - 12.2008
- Managed pharmacy operations, ensuring compliance with FDA regulations and state pharmacy laws, while driving operational efficiency.
- Led project initiatives to improve prescription filling processes, reduce medication errors, and enhance patient safety in line with regulatory standards.
- Developed and implemented safety protocols and best practices for medication handling, ensuring high-quality service and patient care.
- Trained pharmacy staff on GCP and regulatory requirements, fostering a culture of compliance and operational excellence.
Associate Scientist II
Centocor R&D Inc
07.2004 - 03.2008
- Led the development of lyophilization processes for monoclonal antibodies, ensuring compliance with GCP, FDA, and ICH guidelines for clinical trials.
- Managed cross-functional project teams, ensuring timely delivery of technical documentation and adherence to regulatory standards.
- Coordinated the technical transfer of lyophilization processes, ensuring seamless collaboration with internal teams and external partners.
- Authored SOPs and technical reports, maintaining rigorous documentation to meet FDA and EMA regulatory requirements.
Bioprocess Engineer II
Human Genome Sciences
11.2002 - 07.2004
- Directed projects focused on optimizing fill-finish processes for biologics, ensuring compliance with GCP, FDA regulations, and ICH guidelines.
- Managed cross-functional teams to validate manufacturing processes, ensuring quality and regulatory compliance in biologic production.
- Conducted detailed studies on container-closure systems and freeze-thaw techniques to enhance product stability and meet regulatory standards.
- Collaborated with regulatory bodies to ensure adherence to all relevant guidelines, facilitating smooth regulatory submissions.
Education
Clinical Trials Operations Specialization Certificate -
Johns Hopkins University
Doctor of Pharmacy - Pharmacy
University of Florida
01-2015
Master's - Biochemical Engineering
Indian Institute of Technology (Banaras Hindu University)
01.2001
Bachelors - Pharmacy
Chaudhary Charan Singh University
01.1998
Skills
- Clinical Research
- Pharmacovigilance
- Regulatory Compliance and GCP
- Project Management
- Data Management and Analysis
- Patient Safety Monitoring and Management
- Communication & Collaboration
- Problem Solving & Critical Thinking
- Change Management
- Risk Management
- Strategic Thinking
- Financial Management
- Business Development
Certification
- Principles and Practices of Clinical Research - NIH
- Lean Six Sigma Black Belt
- Antibiotic Stewardship - Stanford University
- Certified Project Manager - Google
- Certificate Course in Pharmacovigilance
- Strategic Leadership and Management Specialization -University of Illinois at Urbana-Champaign
- Generative AI for Healthcare
- Epidemiology Course - UNC Chapel Hill
- Immunization Certification - APA
Timeline
Clinical Pharmacist
Advance Community Health
02.2024 - 12.2024
Pharmacy Director & Co-Founder
Youngsville Pharmacy
05.2019 - 12.2024
Clinical Pharmacist
Piedmont Health Services Inc
05.2015 - 01.2019
Pharmacist & Pharmacy Manager
Wal-Mart Stores
01.2010 - 06.2015
Impatient Clinical Pharmacist
Riverview Hospital
01.2009 - 12.2009
Pharmacy Manager
TARGET Stores
01.2008 - 12.2008
Associate Scientist II
Centocor R&D Inc
07.2004 - 03.2008
Bioprocess Engineer II
Human Genome Sciences
11.2002 - 07.2004
Master's - Biochemical Engineering
Indian Institute of Technology (Banaras Hindu University)
- Principles and Practices of Clinical Research - NIH
- Lean Six Sigma Black Belt
- Antibiotic Stewardship - Stanford University
- Certified Project Manager - Google
- Certificate Course in Pharmacovigilance
- Strategic Leadership and Management Specialization -University of Illinois at Urbana-Champaign
- Generative AI for Healthcare
- Epidemiology Course - UNC Chapel Hill
- Immunization Certification - APA
Clinical Trials Operations Specialization Certificate -
Johns Hopkins University
Doctor of Pharmacy - Pharmacy
University of Florida
Bachelors - Pharmacy
Chaudhary Charan Singh University
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