Fiscal Year

2022

Case Number

A-21144-90882

Case Status

Certified

Received Date

2021-10-05

Decision Date

2022-04-12

Refile

N

Original File Date

2022-01-01 11:14:04

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ASTELLAS

Employer Name Slug

astellas

Employer Address 1

DBA ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.

Employer Address 2

1 ASTELLAS WAY

Employer City

NORTHBROOK

Employer City Slug

northbrook

Employer State

ILLINOIS

Employer State Slug

illinois

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

60062

Employer Phone

224-205-8800

Employer Number of Employees

748

Employer Year Commenced Business

2005

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Walter Garcia

Employer Contact Address 1

Astellas Pharma Global Development, Inc.

Employer Contact Address 2

1 Astellas Way

Employer Contact City

Northbrook

Employer Contact State/Province

ILLINOIS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

60062

Employer Contact Phone

224-205-6413

Employer Contact Email

walter.garcia@astellas.com

Agent Attorney Name

Poonam Gupta

Agent Attorney Firm Name

Berry Appleman Leiden LLP

Agent Attorney Phone

(469) 290-9325

Agent Attorney Address 1

11 Times Square

Agent Attorney Address 2

11th Floor

Agent Attorney City

New York

Agent Attorney State/Province

NEW YORK

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

10036

Agent Attorney Email

poonam.gupta@bal.com

PW Track Number

P10020260827055

PW SOC Code

11-9121

PW SOC Title

Clinical Research Coordinators

PW Skill Level

Level IV

PW Wage

158808.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-02-22

PW Expiration Date

2021-06-30

Wage Offer From

158808.00

Wage Offer To

168808.00

Average Salary

163808.00

Wage Unit of Pay

Year

Worksite Address 1

1 Astellas Way

Worksite Address 2

Worksite City

Northbrook

Worksite City Slug

northbrook

Worksite State

ILLINOIS

Worksite Postal Code

60062

Job Title

Clinical Study Manager

Job Title Slug

clinical-study-manager

Minimum Education

Master's

Major Field of Study

Pharmacy, Health/Physical Services, or related

Required Training

N

Required Experience

Y

Required Experience Months

36

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

36

Accept Alternative Job Title

AsiaPacific Regional Lead Study Manager, Country Study Manager, or related role

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Minimum Requirements Masters degree or the foreign equivalent in Pharmacy, HealthPhysical Services, or related, and 36 months in the job offered or as an AsiaPacific Regional Lead Study Manager, Country Study Manager, or related role.br br Alternate Requirements Bachelors degree or the foreign equivalent in Pharmacy, HealthPhysical Services, or related, and 60 months in the job offered or as an AsiaPacific Regional Lead Study Manager, Country Study Manager, or related role.br br Special Skills Three 3 years of experience serving as a project manager for multicountry clinical trials in Oncology at a pharmaceutical company, and three 3 years of experience involving all of the following a Authoring clinical protocols and developing processes for clinical drug development, including study design, study planning, investigative site qualification, and study management and monitoring for budgeting and resource allocations for clinical development programs; b Ensuring compliance with International Conference on HarmonizationGood Clinical Practice ICHGCP guidelines by reviewing submissions of trial applications to ethics committeesindependent review boards and regulatory authorities, including the U.S. Federal Drug Administration FDA, European Medicines Agency EMA, and Pharmaceuticals and Medical Devices Agency PMDA, as well as by supporting inspection readiness through involvement with implementation of corrective and preventive action plans based on internal audit findings; c Developing oncology Patient Informed Consents, numerous supportive Study Plans including the Clinical Monitoring Plan, and Case Report Forms using Medidata RAVE to operationalize study Protocol and data collection; and d Working on global oncology clinical trial development and execution including coordinating involvement and communication between multiregional internal and external stakeholders. Experience may be concurrent.br br Travel Requirement Requires 25 domesticinternational travel.

Combination Occupation

N

Offered to Applicant Foreign Worker

Y

Foreign Worker Live on Premises

N

Foreign Worker Live in Domestic Service

N

Foreign Worker Live in Domestic Service Count

Professional Occupation

Y

Application for College/University Teacher

N

SWA Job Order Start Date

2021-04-09

SWA Job Order End Date

2021-05-11

Sunday Edition Newspaper

Y

First Newspaper Name

Chicago Tribune

First Advertisement Start Date

2021-04-18

Second Newspaper Ad Name

Chicago Tribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-04-25

Employer Website From Date

2022-01-01 11:14:04

Employer Website To Date

2022-01-01 11:14:04

Professional Organization Ad From Date

2022-01-01 11:14:04

Professional Organization Advertisement To Date

2022-01-01 11:14:04

Job Search Website From Date

2021-04-14

Job Search Website To Date

2021-04-28

Employee Referral Program From Date

2022-01-01 11:14:04

Employee Referral Program To Date

2022-01-01 11:14:04

Local Ethnic Paper From Date

2021-04-16

Local Ethnic Paper To Date

2021-04-16

Radio/TV Ad From Date

2021-04-19

Radio/TV Ad To Date

2021-04-20

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

SOUTH KOREA

Foreign Worker Birth Country

SOUTH KOREA

Class of Admission

L-1

Foreign Worker Education

Doctorate

Foreign Worker Information: Major

PHARMACY

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVE.

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BOSTON

Foreign Worker Education Institution State/Province

MA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

2115

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Poonam Gupta

Preparer Title

Senior Counsel

Preparer Email

poonam.gupta@bal.com

Employer Information Declaration Name

Walter Garcia

Employer Information Declaration Title

Associate Director, Human Resources