Fiscal Year

2022

Case Number

A-21173-05124

Case Status

Certified-Expired

Received Date

2021-08-04

Decision Date

2022-02-09

Refile

N

Original File Date

2022-01-01 10:54:46

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

AMGEN INC.

Employer Name Slug

amgen-inc

Employer Address 1

ONE AMGEN CENTER DRIVE

Employer Address 2

Employer City

THOUSAND OAKS

Employer City Slug

thousand-oaks

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

91320

Employer Phone

805-447-1000

Employer Number of Employees

12973

Employer Year Commenced Business

1980

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Jenny Cummings

Employer Contact Address 1

2202 N. Westshore Blvd.

Employer Contact Address 2

Employer Contact City

Tampa

Employer Contact State/Province

FLORIDA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

33607

Employer Contact Phone

813-392-0428

Employer Contact Email

jen01@amgen.com

Agent Attorney Name

Laura Bloniarz

Agent Attorney Firm Name

Berry Appleman Leiden LLP

Agent Attorney Phone

469-290-9687

Agent Attorney Address 1

2400 N. Glenville Dr, Building A

Agent Attorney Address 2

Suite 100

Agent Attorney City

Richardson

Agent Attorney State/Province

TEXAS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

75082

Agent Attorney Email

labloniarz@balglobal.com

PW Track Number

P10020343941350

PW SOC Code

19-1042

PW SOC Title

Medical Scientists, Except Epidemiologists

PW Skill Level

Level I

PW Wage

53810.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-04-20

PW Expiration Date

2021-07-19

Wage Offer From

135003.00

Wage Offer To

0.00

Average Salary

135003.00

Wage Unit of Pay

Year

Worksite Address 1

360 Binney Street

Worksite Address 2

Worksite City

Cambridge

Worksite City Slug

cambridge

Worksite State

MASSACHUSETTS

Worksite Postal Code

2142

Job Title

Global Safety Manager

Job Title Slug

global-safety-manager

Minimum Education

Master's

Major Field of Study

See H.14

Required Training

N

Required Experience

Y

Required Experience Months

24

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

24

Accept Alternative Job Title

See H.14

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

MASTERS DEGREE IN REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES, PHARMACEUTICAL SCIENCE, OR RELATED FIELD AND 2 YEARS OFbr EXPERIENCE INVOLVING THE FOLLOWING DIRECTING, ADVISING, AND AUTHORING SAFETY SECTIONS OF AGGREGATE DATA REPORTS SUCH AS PERIODICbr BENEFITRISK EVALUATION REPORT, PERIODIC SAFETY UPDATE REPORT, PERIODIC ADVERSE DRUG EXPERIENCE REPORT AND DEVELOPMENT SAFETY UPDATEbr REPORT IN ACCORDANCE WITH INTERNATIONAL COUNCIL FOR HARMONIZATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USEbr GUIDELINES TO FULFILL THE REGULATORY REQUIREMENTS OF PERIODIC SAFETY REPORTS FOR MARKETED AND DRUGS UNDER DEVELOPMENT IN CLINICAL TRIALS;br ANALYZING, AND INVESTIGATING SCIENTIFIC AND MEDICAL DATA IN VERBAL AND WRITTEN FORMAT TO PROVIDE ASSESSMENTS OF AGGREGATE SAFETY DATA OFbr DRUGS TO FULFILL REGULATORY REQUIREMENTS FOR PERIODIC AGGREGATE REPORTS AND POSTMARKET COMMITMENTS; UTILIZING SOFTWAREBASED DRUGbr SAFETY SYSTEMS INCLUDING ARGUS AND RAVE TO REVIEW CASES OF ADVERSE EVENTS REPORTED FOR MARKETED DRUGS AND DRUG CANDIDATES IN CLINICALbr TRIALS; AND ANALYZING SCIENTIFIC LITERATURE DATABASES INCLUDING BIOSIS, EMBASE, OR OVID FOR PURPOSE OF IDENTIFICATION OF SAFETY INFORMATION.br br Any suitable combination of education, training, or experience is acceptable.

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

2021-05-18

SWA Job Order End Date

2021-06-17

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2021-05-23

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-05-30

Employer Website From Date

2022-01-01 10:54:46

Employer Website To Date

2022-01-01 10:54:46

Professional Organization Ad From Date

2021-05-20

Professional Organization Advertisement To Date

2021-05-27

Job Search Website From Date

2021-05-20

Job Search Website To Date

2021-05-27

Employee Referral Program From Date

2022-01-01 10:54:46

Employee Referral Program To Date

2022-01-01 10:54:46

Local Ethnic Paper From Date

2021-05-27

Local Ethnic Paper To Date

2021-05-27

Radio/TV Ad From Date

2022-01-01 10:54:46

Radio/TV Ad To Date

2022-01-01 10:54:46

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

REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES

Foreign Worker Years of Education Completed

2018

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

Laura Bloniarz

Preparer Title

Sr. Associate Immigration Attorney

Preparer Email

labloniarz@bal.com

Employer Information Declaration Name

Jen Loretta Cummings Lu

Employer Information Declaration Title

HR Representative