Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

JOHNNY Chowoe PharmD, MBA, BSc

Laurel,USA

Summary

Experienced professional with a strong foundation in quality assurance within pharmacology, manufacturing, and production settings. Skilled in developing quality systems based on precise specifications and protocols. Continuously seeking opportunities to minimize defects and enhance the efficiency of quality program processes.

Overview

9
9
years of professional experience
1
1
Certification

Work History

Pharmacy Regulatory Manager

Greenbelt Pharmacy
05.2024 - Current
  • Supervise pharmacy staff, ensuring compliance and operational efficiency
  • Excellent written and oral communication skills, as well as strong organizational and attention to detail
  • Primary liaison between the company and regulatory authorities such as the FDA, providers, state,
  • Coordinate with healthcare providers and insurance entities for seamless patient care; enhanced collaboration
  • Report to CEO of client portfolio and relationship management.
  • strong track record of CGMP /SOP and its regulations.
  • Supported internal departments in understanding and complying with applicable regulations
  • Monitor treatment programs, offering actionable insights to medical teams, boosting program accuracy
  • Ability to work effectively, individually, and cross-functionally within a team
  • Assist in developing and overseeing medical strategies, ensuring alignment and effectiveness, and optimizing strategic outcomes
  • Excellent operating skills, including timely decisions, and excellent overall time and project management
  • Conducted risk assessments for potential product changes and their impact on regulations
  • Created organizational policies to maintain and enhance regulatory compliance
  • Negotiated favorable terms on consent agreements, minimizing company liability while maintaining good standing with regulators.
  • Conducted thorough reviews of technical documentation to ensure alignment with regulatory standards.
  • Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
  • Developed strong relationships with stakeholders through regular communication updates, fostering trust and confidence in the team''s ability to deliver results.

Medical Director

William KB Foundation INC
12.2019 - Current
  • Company Overview: Non-Profit Medical Organization
  • Lead strategic partnerships and medical affairs, PD&C process, and specific GRS responsibilities
  • Manage budget and financial reporting, ensuring efficient resource utilization and stakeholder trust
  • Develop education plans with medical teams, improving patient care quality and compliance
  • Demonstrating ability to prioritize and organize important tasks
  • Demonstrating abilities in resolving complex issues, including scientific and logical components
  • Implement health programs, understanding global regulatory requirements for drug development and therapeutic treatment
  • Mentored junior staff members on best practices in regulatory affairs management
  • Ability to work and maintain collaborative relationships across the USA, Africa, and the rest of the world
  • Responded promptly to product complaints, investigating concerns, and producing detailed documentation to relevant regulatory personnel
  • Prevented regulatory entanglements by reviewing informational packets and marketing materials in advance
  • Non-Profit Medical Organization

Pharmacist intern: Acute Care & Institutional

Salem Veteran Medical Center
02.2024 - 03.2024
  • Administer acute care, ensuring accurate medication management and patient safety.
  • Manage medication processes to enhance patient care quality.
  • Support critical care assessments to contribute to improved patient outcomes.
  • Recommend drug therapy treatments to providers and medical residents.
  • Educate providers on disease states and treatment guidelines.
  • Strong Knowledge of cGMP, CDMO, QA, FDA etc
  • Develop education plans with medical teams, improving patient care quality and compliance.
  • Recommending enhancements to current risk management and assisting in prevention plans.
  • Developing and implementing risk management strategies, such as adverse effects for patients.
  • Provide timely updates to the medical team on patient risk factors/ management.
  • Ability to community, perform aseptic techniques, and accurately writing skills.

Intern Pharmacist: Ambulatory Care

Tri-Area Community Health
01.2024 - 02.2024
  • Optimized patient medication strategies enhance treatment efficacy and patient outcomes.
  • I refined medication management plans and improved patient care during my internship.
  • Assessed and improved ambulatory care medication plans for accurate treatment results.
  • Pre-checked orders and managed prescription refills to ensure timely medication delivery.
  • Monitored medication therapy management services to help patients achieve optimal health.
  • Strong Knowledge of cGMP, CDMO, QA, FDA etc
  • Develop education plans with medical teams, improving patient care quality and compliance.
  • Recommending enhancements to current risk management and assisting in prevention plans.
  • Developing and implementing risk management strategies such as adverse effects for patients.
  • Provide timely updates to the medical team on patient risk factors/ management.

Intern Pharmacist: Transition Care, Advanced Community, Administration

Kaiser Permanente
06.2023 - 12.2023
  • Streamlined pharmacy processes, enhancing patient care transitions and efficiency.
  • Assisted emergency room patients with bedside medications and therapeutic monitoring.
  • Educated patients on proper medication administration, reducing adverse effects.
  • Monitored employee progress and target achievements.
  • Conducted internal pharmacy inspections and evaluated ASHP guest survey projects.
  • Develop education plans with medical teams, improving patient care quality and compliance.
  • Recommending enhancements to current risk management and assisting in prevention plans.
  • Developing and implementing risk management strategies such as adverse effects for patients.
  • Provide timely updates to the medical team on patient risk factors/ management.

Quality Control Supervisor

Radnet Inc
10.2021 - 06.2023
  • Led team in analyzing guidelines and finished products.
  • Identified and evaluated fundamental problems for major functional areas.
  • Oversaw the development and training of quality control team members.
  • Reviewed and updated the company's Quality Management System QMS as needed to maintain compliance with standards.
  • Ensured proper documentation of all quality control activities, including corrective actions taken.
  • Investigated customer complaints related to product quality issues and recommended solutions.
  • Trained and supervised quality control technicians in their daily tasks.
  • Completed investigations, root cause analyses, and quality troubleshooting activities.
  • Optimized QC team performance by overseeing assignments, schedules, and training.
  • Ordered new materials and equipment based on expected demand and maintenance needs.

Project Manager

Kahak Healthcare Services
12.2019 - 10.2021
  • Supervised daily operations, ensuring compliance with policies and regulations, enhancing efficiency.
  • Developed strategic plans with clear objectives, leading to measurable improvements in team performance.
  • Analyzed market trends and competitive data to provide insights, driving informed decision-making.
  • Contributed to global commercial strategy, overseeing project execution and intake meetings.
  • Manage a team of professionals and compliance related to company policies and guidelines
  • Identified business opportunities in key therapeutic areas, boosting program enrollment.
  • Closed out completed projects by conducting post-mortem evaluations identifying areas of improvement for future initiatives.
  • Implemented lessons learned from past projects in order to continuously improve overall performance over time.
  • Established change management processes to handle alterations in scope or direction during various stages of projects.
  • Identified project requirements by collaborating with stakeholders and team members.
  • Collaborated with senior leadership to align projects with organizational goals and strategies.
  • Ensured quality control by establishing standards and conducting regular reviews of deliverables against set criteria.
  • Trained team members on project management tools, processes, and best practices to improve overall efficiency.

Regulatory Affairs Specialist

AmerisourceBergen Pharmaceutical
08.2016 - 12.2019
  • Led market research design and execution, delivering insights for strategic decisions.
  • Translated business needs into actionable research, enhancing operational excellence.
  • Supported accurate diagnosis for Sabril patients through targeted campaign efforts.
  • Managed data collection, vendor coordination, and intelligence dissemination.
  • Researched medical and pharmacy benefits for specialty medications.
  • Reviewed promotional materials for accuracy and adherence to regulatory guidelines before approval.
  • Prepared and submitted documentation for new product registrations, renewals, variations, and license transfers.
  • Supported global expansion efforts by researching international regulations and assisting with market entry strategies.
  • Collaborated with research and development teams to ensure products met all applicable standards before submission for approval.
  • Managed communication with regulatory agencies to obtain necessary approvals and maintain good working relationships.
  • strong track record of CGMP /SOP and its regulations
  • Supported product lifecycle management initiatives by providing input on potential regulatory implications of proposed changes.
  • Assisted in preparing annual reports on company performance related to compliance with regulations.

Education

Doctor of Pharmacy - Pharmacy - Graduated

Appalachian College of Pharmacy
Oakwood,VA

MBA - MBA & Healthcare Management - Graduated

University of Pikeville
Pikeville, KY

Bachelor of Science - Biology - Graduated

Bowie State University
Bowie, MD

Associate of Science - Pre-Pharmacy / General Studies - Graduated

Prince George's Community College
Largo, Maryland

Skills

  • KOL Management
  • Scientific Presentation
  • Policy Development
  • Verbal Communication
  • Written Communication
  • Experienced
  • FDA Regulations
  • Clinical Trials
  • Leadership
  • Data Analysis
  • Critical Thinking
  • Excel
  • MS Word
  • Risk management
  • ISO standards
  • Cross-functional team leadership
  • Global regulatory compliance
  • Document management
  • Medical device regulations
  • Pharmaceutical industry
  • Business correspondence management
  • Leadership skills
  • SOP development
  • Negotiation skills
  • Time management abilities
  • CGMP
  • Clinical studies
  • Healthcare management
  • Patient health education
  • Clinical quality improvement
  • Business development
  • Strategic planning
  • Clinical leadership
  • Clinical research
  • Clinical staff management
  • Analytical thinking

Certification

  • Board Certified Medical Affairs Specialist
  • Pharmacist Intern License: MD, VA & KY
  • National Council for Behavior Health: Mental Health USA Cert
  • American Heart Association Basic Life Support and AED
  • APhA: Pharmacy-Based Immunization Delivery
  • USP 797 Sterile Compound Training and Certification
  • National Safety Compliance: OSHA/HIPAA Certificates
  • Semester-Base Undergraduate Research certificate
  • Two Teacher Training Certificates

Timeline

Pharmacy Regulatory Manager

Greenbelt Pharmacy
05.2024 - Current

Pharmacist intern: Acute Care & Institutional

Salem Veteran Medical Center
02.2024 - 03.2024

Intern Pharmacist: Ambulatory Care

Tri-Area Community Health
01.2024 - 02.2024

Intern Pharmacist: Transition Care, Advanced Community, Administration

Kaiser Permanente
06.2023 - 12.2023

Quality Control Supervisor

Radnet Inc
10.2021 - 06.2023

Medical Director

William KB Foundation INC
12.2019 - Current

Project Manager

Kahak Healthcare Services
12.2019 - 10.2021

Regulatory Affairs Specialist

AmerisourceBergen Pharmaceutical
08.2016 - 12.2019

Doctor of Pharmacy - Pharmacy - Graduated

Appalachian College of Pharmacy

MBA - MBA & Healthcare Management - Graduated

University of Pikeville

Bachelor of Science - Biology - Graduated

Bowie State University

Associate of Science - Pre-Pharmacy / General Studies - Graduated

Prince George's Community College

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JOHNNY Chowoe PharmD, MBA, BSc
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