Fiscal Year

2022

Case Number

A-21265-48103

Case Status

Certified

Received Date

2021-12-21

Decision Date

2022-08-01

Refile

N

Original File Date

2022-01-01 11:48:08

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ASTRAZENECA PHARMACEUTICALS LP

Employer Name Slug

astrazeneca-pharmaceuticals-lp

Employer Address 1

1800 CONCORD PIKE

Employer Address 2

Employer City

WILMINGTON

Employer City Slug

wilmington

Employer State

DELAWARE

Employer State Slug

delaware

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

19897

Employer Phone

302-886-3000

Employer Number of Employees

76100

Employer Year Commenced Business

1966

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Echeverri Adriana

Employer Contact Address 1

One MedImmune Way

Employer Contact Address 2

Employer Contact City

Gaithersburg

Employer Contact State/Province

MARYLAND

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

20878

Employer Contact Phone

301-398-0209

Employer Contact Email

adriana.echeverri@astrazeneca.com

Agent Attorney Name

Hyla K Rosenberg

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy LLP

Agent Attorney Phone

2126888555

Agent Attorney Address 1

1400 Broadway

Agent Attorney Address 2

Agent Attorney City

New York

Agent Attorney State/Province

NEW YORK

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

10018

Agent Attorney Email

ACharniauskaya@fragomen.com

PW Track Number

P10021078161467

PW SOC Code

15-1121

PW SOC Title

Computer Systems Analysts

PW Skill Level

Level III

PW Wage

116667.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-08-20

PW Expiration Date

2022-06-30

Wage Offer From

116667.00

Wage Offer To

0.00

Average Salary

116667.00

Wage Unit of Pay

Year

Worksite Address 1

One MedImmune Way

Worksite Address 2

Worksite City

Gaithersburg

Worksite City Slug

gaithersburg

Worksite State

MARYLAND

Worksite Postal Code

20878

Job Title

Regulatory Information Manager

Job Title Slug

regulatory-information-manager

Minimum Education

Master's

Major Field of Study

Regulatory Affairs, Life Science, Computer Science, Information Technology or rel

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

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

36

Accept Alternative Job Title

Regulatory Analyst, Developer, or rel

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must have a Masters degree or foreign equivalent in Regulatory Affairs, Life Science, Computer Science, Information Technology or a related field plus three 3 years of experience in the position offered, as a Regulatory Analyst, Developer, or a related position. Must have three 3 years of experience in each of the following System administration for validated applications within a regulated environment; Data Management and Regulatory Information Management of regulatory records pertaining to multiple regulatory Applications including Investigational New Drug Application IND, New Drug Application NDA, Biologic License Application BLA, Marketing Authorization Application MAA, and Adverse Events AE; Maintaining regulatory application indexes, tracking of regulatory submissions and special projects; Support system implementation for Document Management including CARA, Sharepoint, Registration Data Tracking Systems, Veeva Vault Cloud Technology and eCTD; Change Request Management activities, analyzing system requirements within user stories, developing test scripts and conduct UAT, migration and integration testing; Micro Focus Application Lifecycle Management ALM system and JIRA tool; Document and submission publishing tools including eCTD Xpress, FirstDoc, ISI ToolBox; and Regulatory information management for medical devices and combination products.

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

2021-07-08

SWA Job Order End Date

2021-08-13

Sunday Edition Newspaper

Y

First Newspaper Name

The Washington Post

First Advertisement Start Date

2021-07-11

Second Newspaper Ad Name

The Washington Post

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-07-18

Employer Website From Date

2021-07-08

Employer Website To Date

2021-09-24

Professional Organization Ad From Date

2022-01-01 11:48:08

Professional Organization Advertisement To Date

2022-01-01 11:48:08

Job Search Website From Date

2021-07-11

Job Search Website To Date

2021-07-18

Employee Referral Program From Date

2022-01-01 11:48:08

Employee Referral Program To Date

2022-01-01 11:48:08

Local Ethnic Paper From Date

2021-07-14

Local Ethnic Paper To Date

2021-07-14

Radio/TV Ad From Date

2022-01-01 11:48:08

Radio/TV Ad To Date

2022-01-01 11:48:08

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

INDIA

Foreign Worker Birth Country

INDIA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

COMPUTER SCIENCE

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

TEXAS AM UNIVERSITY KINGSVILLE

Foreign Worker Education Institution Address 1

700 UNIVERSITY BLVD

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

KINGSVILLE

Foreign Worker Education Institution State/Province

TX

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

78363

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Hyla K Rosenberg

Preparer Title

Partner

Preparer Email

ACharniauskaya@fragomen.com

Employer Information Declaration Name

Adriana Echeverri

Employer Information Declaration Title

Global Mobility Advisor