Regulatory Affairs, Pharmacist
Resume:
MONICA
J.
CHOI,
PHARM.D.
Chestnut
Street
Apt
206,
Chicago,
IL
60611 ac7kxr@r.postjobfree.com
Education MIDWESTERN
UNIVERSITY Downers
Grove,
IL Doctorate
of
Pharmacy
–
May,
2018 LOYOLA
MARYMOUNT
UNIVERSITY Los
Angeles,
CA Bachelor
of
Science
in
Chemistry
–
August,
2013 Licenses REGISTERED
PHARMACIST-
CALIFORNIA,
NEW
JERSEY Work
Experience
02/2016
–
05/2017 INFECTIOUS
DISEASE
RESEARCH Downers
Grove,
IL Researcher • Prepared
azithromycin
exposure
in
the
treatment
of
Psuedomonas
aeruginosa pneumonia-
a
population
pharmacokinetic
approach
study
• Drafted
and
revised
the
Institutional
Review
Board
(IRB)
protocol
for
submission
to Midwestern
University
and
Northwestern
Memorial
Hospital
Institutional
Review Board
for
university
grants
• Reviewed
primary
literature
on
renal
toxicities
and
safety
profile
associated
with Vancomycin
05/2015
–
07/2015 SORRENTO
THERAPEUTICS San
Diego,
CA CMC
/
Pharmacovigilance
Intern
• Prepared
and
reviewed
the
Chemistry,
Manufacturing,
and
Control
(CMC)
section
for FDA
regulatory
submission
with
regulatory
and
pharmacovigilance
team
• Evaluated
safety
profiles
and
assisted
drafting
updated
safety
reports
for
oncology drugs
• Assisted
in
managing
revision
control
of
the
Standard
Operating
Procedure
(SOP) manual
and
master
files
for
quality
control
team 09/2013
–
07/2014 SORRENTO
THERAPEUTICS Irvine,
CA Regulatory
Affairs
Associate
• Preparation,
compilation,
and
submission
of
regulatory
IND
and
NDA
for
oncology products
to
US/EU
regulatory
agencies;
Ensured
that
all
regulatory
activities
are compliant
with
FDA
Code
of
Federal
Regulations
Title
21
• Utilized
Biostatistics
to
prepare
and
analyze
oncology
non- clinical,
phase
2,
and phase
3
bioequivalence
trial
data
• Involved
in
nonclinical
study
management
including
contract
initiation,
study
design, study
monitoring,
data
analysis,
and
GLP
auditing
• Submitted
annual
reports
and
amendments
to
the
FDA
to
update
registered
product information
• Reviewed
pharmacovigilance
aspects
of
protocols
and
managed
adverse- event
case reports
Pharmacy
Experience
02/2018
–
04/2018 NORTHWESTERN
MEMORIAL
HOSPTIAL Chicago,
IL Intern
Pharmacist • Completed prior authorizations (PA) for specialty drugs, set up drug assistance programs,
and
counseled
patient’s
HIV
drug
regimen
• Assisted patients on drug copay assistance and managed refilling specialty medications
• Counseled
patient’s
medication
compliance
and
performed
medication
reconciliation 10/2017
–
11/2017 MARIANO’S
PHARMACY Chicago,
IL Intern
Pharmacist • Counseled patients on new prescription and appropriate use of drugs such as injections
and
COPD
inhalers
• Participated
in
flu
clinics
in
Chicago
land
and
administered
shingles,
pneumococcal, Tdap
vaccines
• Performed
blood
glucose,
hemoglobin
A1C,
and
cholesterol
tests
to
patients
and counseled
on
their
lifestyle
management 08/2017
–
10/2017 AON
CONSULTING
-
RISK
MANAGEMENT Chicago,
IL Intern
Pharmacist • Provided
recommendations
to
Pharmacy
Benefit
Manager
(PBMs)
related
to
drug formulary,
plan
design,
and
clinical
programs
• Reviewed
drug
formularies
and
drug
utilization
reviews
(DUR)
for
major
corporate clients
• Prepared
opioid
addiction
management
report
to
pharmaceutical
company’s seminars
and
PBM
conferences
10/2014
–
02/2015 WALGREENS Aurora,
IL Student
Pharmacist • Engaged
in
medication
dispensing,
prescription
medication
consultation,
and diabetes
screenings
• Communicated
with
health
care
providers
to
better
coordinate
patient
care Certification Illinois
Certified
Pharmacy
Technician
(CPhT),
California
Certified
Pharmacy
Technician
(CPhT),
Good
Clinical
Practice
Certification
(GCP),
Immunization
Certification,
Basic
Life Support
(BLS)
CPR
Certification,
HIPPA
Certification,
Occupational
Safety
and
Health Administration
Certification
(OSHA),
Statistical
Analysis
Systems
(SAS)
Education Certification
Skill Statistical
Analysis
Systems
(SAS),
Graphpad
Prism,
Endnote,
JMP
statistical
software,
ISI Writer,
HIPPA
trained,
Fluent
in
Korean
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