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Dr. Dena Bayoumi, PharmD

: New Jersey, USA : 732-***-**** ️: adyfg8@r.postjobfree.com Doctor of Pharmacy, PharmD – Fairleigh Dickinson University School of Pharmacy and Health Sciences [FDU] Florham Park, NJ; 2016 - Graduation May 2022

Masters Coursework, The New Pathways to Teaching, Certified Teacher – New Jersey City University at Raritan Valley Community College, Teacher Development & Instruction

Bachelors of Arts, Biological Sciences – Rutgers University, Rutgers College, New Brunswick, NJ Bachelors of Arts, Psychology – Rutgers University, Rutgers College, New Brunswick, NJ Licensed Certified Nursing Assistant – HoHoKus School at Bergen Regional Medical Center, Paramus, NJ Basic Life Support, CPR, and AED Program – American Red Cross & American Heart Association, LifeSavers Inc. Certified Diabetes Caregiver and Educator – APhA, The Pharmacist & Patient-Centered Diabetes Care Certificate Training Program Certified Immunizer – APhA, Pharmacy-Based Immunization Delivery Certificate Training Program Delivering Medication Therapy Management Services Certification – APhA, Managing Medication Regimens Training Program CITI Research Program Certification – Collaborative Institutional Training Initiative; Biomedical Research, Ethics of Human Subjects, IRB Regulations, Informed Consent & Conflicts of Interest for Investigators and Staff involved in biomedical research with human subjects Safety & Privacy: OSHA – Occupational Safety and Health Administration; HIPAA – Health Insurance Portability & Accountability Act; Protecting Against Blood Borne Pathogens; SDS – Safety Data Sheets & Safe Handling of Hazardous Drugs & Chemical Spills New Jersey Pharmacy Technician – New Jersey Office of the Attorney General, Division of Consumer Affairs, Board of Pharmacy Pharmacist’s Patient Care Process

Medication History & Prescription

Reconciliation

Identification of Drug-Related

Problems

Patient Safety & Counseling

Patient Physical Assessment

Pharmacotherapy Rounds

Inter-professional Consultation

Clinical Interventions

Medical Terminology

Pharmaceutical Calculations

Ethics Proficiency & Legal

Behavior/Pharmacy Law

Insurance/Rx Drug Coverage

Microsoft Office 365: Word, PowerPoint, Excel, Access, SharePoint; Google Suite: Docs, Slides, Sheets, OneNote; Systems: EPIC EMR, Citrix Workspace, EDIMs, Cerner, Lawson, RxConnect & 2000, UNIX, Oracle, WINLIMS, Adobe, Kodak-COCOON, CONNECT, Maestro, Watson, SAP, SPASS, Sales Force Automation; Conferencing: Zoom, Microsoft Teams, Go To Meetings & Webinar; Arabic, Intermed. French

Johnson & Johnson Product Analyst and Medical Claims Specialist - Medical & Clinical Affairs o May 2015 - June 2016; Skillman, NJ

CVS Pharmacy Pharmacist Technician

o December 2008 - February 2015; Bedminster, Budd Lake, Hillsborough & various NJ locations

Robert Wood Johnson, Somerset Medical Center Unit Secretary - Emergency Room o December 2012 - May 2014; Somerville, NJ

Tandem Labs/Lab Corp QC Data Specialist

o October 2008 - November 2008; Ewing, NJ

MCMC School & Darul Arqam School Teacher - English, Arabic, Ethics, & General Education 1st - 12th Grades o May 2007 - Sept. 2008; Piscataway & South River, NJ

BASF-The Chemical Company Documentation & Product Regulatory Associate - Environmental Health & Safety & Regulatory o January 2007 - May 2007; Florham Park, NJ

The NeoStrata Company, Inc. Research Scientist - Research & Development, Neoceuticals, Cosmeceuticals, Skin & Body o September 2005 - January 2007; Princeton, NJ

Schering-Plough Research Institute Metrology Specialist - Analytical Development o November 2004 - December 2004; Kenilworth, NJ

EDUCATION & CERTIFICATIONS

SUMMARY STATEMENT Doctor of Pharmacy and Certified Educator with 15+ years experience in pharma specialties including Medical & Clinical Affairs and Research & Development. Proficient knowledge of drugs, pharmaceuticals, OTC, and medical products & devices, pharmacy, drug safety, adverse events, side effects, medical information & education, therapeutic guidelines, and literature research & analysis. Skilled in attention to detail, organization, analyzation, multi-tasking, management, administration, communication, courteous patient care, medical writing & editing, documentation, electronic medical records, customer/patient & medical inquiries, complaints, issues with drugs & products, troubleshooting & providing resolutions. Possess experience in clinical research, patient cases

& narratives, patient physician liaison, clinical support, patient relations, healthcare practitioner inquiries, regulatory, pharmacovigilance, database management, good clinical practice, good lab practice, quality control, quality assurance. Seeking a high-level career position to help improve the quality of life and health outcomes of others. PHARMACIST COMPETENCIES & TECHNOLOGY

PROFESSIONAL EXPERIENCE

2 Dr. Dena Bayoumi, PharmD

Merck & Co., Inc. Senior Industrial Hygiene Technician - Industrial Hygiene Lab o November 2003 - March 2004; Rahway, NJ

Merck & Co., Inc. Repository Staff Technician - Sample Repository/Compound Management Group o April 2003 - November 2003; Rahway, NJ

L’Oreal USA, Inc. Jr. Chemist - Fragrance Research & Development o February 2002 - October 2002; Clark, NJ

Johnson & Johnson Consumer Products Worldwide Formulations Chemist - Oral Care Product Development o August 2001 - December 2001; Skillman, NJ

Warren Family Dental Dental Assistant

o May 1998 - August 2001; Warren, NJ

Overlook Medical Center Hospital, Ambulatory Care: Summit, NJ

New Jersey Poison Information & Education System - Toxicology, New Jersey Medical School: Newark, NJ

Stop & Shop Pharmacy, Retail: Union & Middletown, NJ

Hikma Pharmaceuticals, Pharmaceutical Industry: Eatontown, NJ

Qualitas Pharmacy Services, Specialty, Long Term Care Services, Mail Order: South Plainfield, NJ

Morristown Medical Center Hospital, Acute Care & Ambulatory Care: Morristown, NJ

Saint Joseph's University Hospital, Institution: Paterson, NJ

Bowker's Pharmacy, Independent: Milford, NJ

Interfaced with clinical research organizations and departments at Johnson & Johnson, hospitals, and other pharmaceutical groups: Regulatory, Marketing, Pharmacy, Special Materials, Law – to coordinate study design, timing, and special requests

Comprehensive copy review to ensure efficacy of clinical research data for product claims substantiation including product packaging

& inserts, educational information, literature, internet material, website search terms, labels, product displays, advertisements – printed and video, coupons, and supplemental material; supported PR review of consumer facing materials – including print, web, televised, audio, video

Researched & compiled documentation for claims support verification, development plans, and Annual Product Reviews, prior to commercialization and various product copy release; created and maintained claims library and supporting data for key product lines

Operated Covid-19 Medical Information and Assistance Hotline, & electronically documented patient case narratives – New Jersey Poison Information, Education, & Toxicology System; delivery of patient education & preventive health therapies

Multi-tasking in fast-paced environment; precise, clinical order entry of prescriptions, pharmacy math; medication preparation: measuring, counting, compounding, flavoring, & labeling; regulation compliance: DEA, FDA, Board of Pharmacy, Biohazard, Dept. of Health

With consent & GCP collected specimens from patients; conducted experimentation, analyzed lab data; National Institute of Health grant proposal research submission; prepared medical writing requests, outlines, summaries, status reports, memos, graphs, charts, tables, slides

Coordinated Emergency Department events: Codes MI, Stroke, Cardiac Arrest, CPR in Progress, Mental Health, Security emergencies

EMR intra & inter facility managing Dr’s orders & coordination of activities: pharmacy medications, verification of RXs, admissions, discharges, transfers, patient activity, isolation, precautions, DNR/DNI, vitals, monitoring, telemetry, nursing care, nutrition, dietary, lab work, blood & diagnostic tests, rehab, consults, radiology, cardiology, vascular, respiratory/pulmonary, equipment, & medical supplies

Efficient liaison between healthcare, regulatory, & pharmaceutical personnel, auditing bodies, scientists, Quality Assurance, Quality Control, & vendors. Identified problems and informed of resolutions. Maintained database records, memos, addressed modifications, & resolved requests for pharmacies, healthcare facilities, supplier MSDS, Certificates of Analysis, Toxic Substances Control Act Compliance Report Forms, OSHA, & prescription compliance.

Extracted, reviewed, & updated regulatory data into computerized libraries for: drug properties, raw material product chemical composition, environmental & toxicological statistics, federal & international regulations, and import & export blocks.

Regulatory, healthcare professional, GCP, GLP, GMP training. Maintained regulatory records & lab documentation. Wrote SOPs for employees & consultants. QC of pharmaceutical products against standards. Analytical lab microbiology testing.

Integrated knowledge of healthcare & pharmaceutical industries, managed care, Medicare, Medicaid, & reimbursement channels to support Data Operations and handle medical & pharmacy data requests for over 800+ drugs

Researched, compiled, & evaluated clinical data, medical writing, & source materials with high attention to detail to extract data for pharmacy drug formularies & medical questions for prescription, speciality & medical drugs, & consumer products, including those for complex and chronic disease states; classified data into databases for statistical analysis to represent clinical data findings & provide timely deliverables to clients while maintaining data accuracy; managed large volumes of data for drug step therapies, prior authorization criteria, and infusion & injectable drugs, extensive IQVIA Data research, analyzation, & spreadsheet management. CLINICAL PHARMACY EXPERIENCE

MEDICAL & CLINICAL AFFAIRS and HEALTH CARE

PHARMACEUTICAL DATA MANAGEMENT

REGULATORY & COMPLIANCE

3 Dr. Dena Bayoumi, PharmD

CAPA: address & prevent customer & patient complaints; results oriented interaction and effective communication skills with Quality Control team members, project leaders, Sample Management, & Quality Assurance departments to report problems and suggest solutions

Proficient in discerning data discrepancies: reviewed sample prep documentation, stability data, & raw lab data for accuracy and adherence to SOPs & GLP policies; identified problems & errors and informed QC Auditors & Specialists

Managed Industrial Hygiene samples from Merck Research Labs worldwide to ensure compliance of Merck drug development for all clinical trial phases; responsible for updating Chemical Inventory Database for Industrial Hygiene Lab Reference Standards & Samples using ACCESS ID system; kept data current for 400+ in-house compounds; conducted GLP analysis of Total Dust samples; reviewed data, performed calculations, created Certificates of Analysis; logged & managed samples with Windows Library Information Management System; key player in logging-in & managing 7900+ samples for year-end 2003, 1300+ samples in 2004

Formulated, compounded, flavored, & fragranced hundreds of OTC, personal, & baby products using GLP, targeting self-care, beauty, & therapeutic uses: acne, skin diseases, anti-wrinkle, skin moisturization, protection, renewal, alphahydroxy & polyhydroxy acids & general care. Aided in scale-up to GMP pilot lab.

Accurately tested, & evaluated: product stability, characterization, desirability, packaging compatibility, pH, viscosity, specific gravity, integrity, odor, & Quality Control. Extracted data from databases for 100’s of GMP manufacturing batches, prepared comprehensive tables; proposed new specs based on trends. Generated product, process, and raw material research specifications.

Creatively focused on appeal to consumer market & needs, & catered to target markets. Shipped samples to clients. Studied trends in personal care markets through fiches & research of industry news, literature, & statistics. Coordinated product use tests to simulate real consumer use conditions. With consent, consumer tested products for product performance at in-house clinics.

Wrote protocols, conducted tests, analyzed returned client samples, summarized, & reported findings. Analyzed data, drew conclusions, and generated written reports. Prepared product samples & submission memos for marketing approval.

Served Merck worldwide through the timely distribution of 1,000’s of clinical research testing samples using UNIX and Oracle software/computerized material management systems to fulfill scientists’ requests. Utilized Robotic Liquid Handlers, and manual transfer of samples into aliquot plates. Key team contributor in transfer of 485,000 dry compounds & 471,000 solution samples of various test quantities

(2.2 million vessels total) into Automated Compound Distribution Center.

Clinical Trials Administration – A Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against BCMA (B-Cell Maturation Antigen), Indication: Patients With Relapsed or Refractory Multiple Myeloma

Operational Plan – Writing Informed Consent, High Level Overview: Manufacturing of Drug/Blood, Overview of CAR-T Cell Therapy, Clinical Trial Study Data Analyzation, Projected Study Timelines, Medical Feasibility, Clinical Trial Purpose & Study Design, Operational Feasibility, Risk Management – Side Effects, Enrollment, Budget, Recruitment Strategy, Scenario Planning, Outcomes, Recommendation

Principal Investigator in Original Research, Evaluation of FDU Pharmacy Students’ Class Attendance and Overall Performance; Approved by FDU Institutional Review Board, Department of Human Research Compliance; Survey data analyzation via Qualtrics Metrics

Dermatology: Retin-A NDA [New Drug Application to the FDA]; OTC & Rx Drug Counseling; Ingredients & Allergic Contact Dermatitis

Healthcare Provider, Patient Education, & In-services: Cardiology; Hematology; Oncology; Neurology; Psychiatry; Nephrology; Endocrinology; Medication Adherence; Awareness of Cultural Health Beliefs; Pre-Diabetes & Type 2 Diabetes Prevention; Pharmacological

& Non-Pharmacological Therapy; Top OTC Pharmacist Recommendations; Accessibility & Comparison: In-Person Visits vs Telehealth

Health Care Team Communication: Interprofessional Education Day – TOURO, New York College of Osteopathic Medicine, Medicine-Dentistry-Pharmacy – Patient Case Collaborations, Key Communication Principles

TeamSTEPPS – Team Strategies and Tools to Enhance Performance and Patient Safety, Interprofessional Education: Pharmacy and Nursing Collaboration in a Clinical Setting – Patient Cases, Hospital Emergency Room

Infectious Diseases: Pneumonia, Influenza, Vaccinations, Covid-19 [Moderna & Pfizer Vaccines] and Journal Clubs: o “Effect of Remdesivir vs Standard Care on Clinical Status of Patients With Moderate COVID-19.” o “Effect of Calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study.” o “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.” (Pfizer-BioNTech) Service Learning Geriatrics Population – Student Pharmacist Volunteer, The Villa Home Assisted Living; Florham Park, NJ Organizations: APhA – American Pharmacists Association; NJSHP – New Jersey Society of Health-System Pharmacists; SPA – Student Pharmacist’s Association - Peer Mentor; NJPhA – New Jersey Pharmacists Association; IPhO – Industry Pharmacists Organization Flu Clinics & Health Fairs – Flu vaccinations & free health screenings, CVS Pharmacies & collaborations at various NJ locations Pharmacist’s Letter – drug therapy, pharmacy practice & training, continuing education Robert Wood Johnson Medical School – Homeless & Indigent Population Health Outreach Project: free health care services to the impoverished, focus on OBGYN women's services; shadowed Drs St. Peter’s University Hospital – Extracellular Matrix Women's & Infant's Health Group; shadowed Drs & researchers, clinical research focus circles to promote healthy mothers & babies and methods to obtain federal clinical research funding PHARMACY RESEARCH & CLINICAL KNOWLEDGE

PROFESSIONAL & LEADERSHIP ACTIVITIES

RESEARCH & DEVELOPMENT

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