Fiscal Year

2022

Case Number

A-21132-85758

Case Status

Certified-Expired

Received Date

2021-05-28

Decision Date

2021-10-22

Refile

N

Original File Date

2022-01-01 10:18:28

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ASTELLAS INSTITUTE FOR REGENERATIVE MEDICINE

Employer Name Slug

astellas-institute-for-regenerative-medicine

Employer Address 1

1 ASTELLAS WAY

Employer Address 2

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

847-970-2573

Employer Number of Employees

1400

Employer Year Commenced Business

2015

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

WALTER GARCIA

Employer Contact Address 1

1 ASTELLAS WAY

Employer Contact Address 2

Employer Contact City

NORTHBROOK

Employer Contact State/Province

ILLINOIS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

60062

Employer Contact Phone

847-226-1171

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@balglobal.com

PW Track Number

P10020170664640

PW SOC Code

11-9121

PW SOC Title

Natural Sciences Managers

PW Skill Level

Level III

PW Wage

121909.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-10-19

PW Expiration Date

2021-06-30

Wage Offer From

122000.00

Wage Offer To

132000.00

Average Salary

127000.00

Wage Unit of Pay

Year

Worksite Address 1

9 Technology Drive

Worksite Address 2

Worksite City

Westborough

Worksite City Slug

westborough

Worksite State

MASSACHUSETTS

Worksite Postal Code

1581

Job Title

Clinical Study Manager

Job Title Slug

clinical-study-manager

Minimum Education

Master's

Major Field of Study

Ophthalmology, Optometry, or related field in Vision/Health Science

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

See H.14

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Minimum Requirements Masters degree or the foreign degree equivalent in Ophthalmology, Optometry, or related field in VisionHealth Science, and 36 months of experience in the job offered or related.br br Alternate Requirements Bachelors degree or the foreign degree equivalent in Ophthalmology, Optometry, or related field in VisionHealth Science, and 60 months of experience in the job offered or related.br br Special Skills Two 2 years of experience planning, initiating, and executing clinical studies in Ophthalmology, and involving all of the following a Developing Clinical Study plans and system setup, establishing and implementing drug development protocols and processes and monitoring and producing compliant case report forms CRF, informed consent forms ICF, and clinical study reports CSR; b Conducting systematic evaluation of study data for accuracy and quality assurance and ensuring compliance with Good Clinical PracticeInternational Council for Harmonization GCPICH and other regulatory requirements from the European Medicines Agency EMA and the U.S. Food and Drug Administration FDA; and c Identifying ocular structural and functional endpoints using various imaging modalities, including Fundus Photography, Optical Coherence Tomography, Fundus Fluorescein Angiography, Electroretinography, Scanning Laser Ophthalmoscopy, and Adaptive Optics Retinal Imaging. Experience may be concurrent.br br 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

2021-02-23

SWA Job Order End Date

2021-03-31

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2021-03-07

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-03-14

Employer Website From Date

2022-01-01 10:18:28

Employer Website To Date

2022-01-01 10:18:28

Professional Organization Ad From Date

2022-01-01 10:18:28

Professional Organization Advertisement To Date

2022-01-01 10:18:28

Job Search Website From Date

2021-03-08

Job Search Website To Date

2021-03-19

Employee Referral Program From Date

2022-01-01 10:18:28

Employee Referral Program To Date

2022-01-01 10:18:28

Local Ethnic Paper From Date

2021-03-12

Local Ethnic Paper To Date

2021-03-12

Radio/TV Ad From Date

2021-03-09

Radio/TV Ad To Date

2021-03-10

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

NEPAL

Foreign Worker Birth Country

NEPAL

Class of Admission

H-1B

Foreign Worker Education

Doctorate

Foreign Worker Information: Major

VISION SCIENCE

Foreign Worker Years of Education Completed

2017

Foreign Worker Institution of Education

UNIVERSITY OF ALABAMA AT BIRMINGHAM

Foreign Worker Education Institution Address 1

1720 2ND AVE. SOUTH

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BIRMINGHAM

Foreign Worker Education Institution State/Province

AL

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

35294

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@balglobal.com

Employer Information Declaration Name

Walter Garcia

Employer Information Declaration Title

Associate Director, Human Resources