Fiscal Year

2020

Case Number

A-19324-85579

Case Status

Certified

Received Date

2020-01-22

Decision Date

2020-05-20

Refile

N

Original File Date

2020-01-01 08:19:03

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

21973

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

Agent Attorney Phone

9728617144

Agent Attorney Address 1

2400 N. Glenville Dr

Agent Attorney Address 2

Building A

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

P10019029082949

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

72446.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-05-30

PW Expiration Date

2019-08-28

Wage Offer From

93516.00

Wage Offer To

0.00

Average Salary

93516.00

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

Senior Associate Regulatory Affairs

Job Title Slug

senior-associate-regulatory-affairs

Minimum Education

Master's

Major Field of Study

Regulatory Affairs in Drugs, Biologics and Medical Devices, Biotechn, Life Science, or related field

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

N

Foreign Language Required

N

Specific Skills

MASTERS DEGREE IN REGULATORY AFFAIRS IN DRUGS, BIOLOGICS AND MEDICAL DEVICES, BIOTECHNOLOGY, LIFE SCIENCE OR RELATED FIELD, AND 2 YEARS OFbr RELATED WORK EXPERIENCE. MUST HAVE EXPERIENCE IN THE PHARMACEUTICAL OR BIOTECHNOLOGY INDUSTRY. MUST HAVE 2 YEARS OF EXPERIENCE IN ASSESSING NONCONFORMANCES AND RECOMMENDING CHANGE CONTROLS; USING VARIOUS ELECTRONIC DOCUMENTbr MANAGEMENT SYSTEMS EDMS TOOLS; AUTHORIZING ANNUAL REPORT SUMMARIES FOR ANNUAL REPORTS SUBMISSIONS; ASSISTING WITH THE PREPARATION FORbr THE FDA BIANNUAL INSPECTIONS; EVALUATING AND REPORTING MANUFACTURING CHANGES THAT IMPACT THE SUBMISSION; DEVELOPING REGULATORY STRATEGIESbr AND MANAGING SUBMISSION PLANNING; AND HANDLING QUERIES FROM VARIOUS REGULATORY AUTHORITIES. 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

2019-07-26

SWA Job Order End Date

2019-08-27

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2019-09-08

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-09-15

Employer Website From Date

2020-01-01 08:19:03

Employer Website To Date

2020-01-01 08:19:03

Professional Organization Ad From Date

2019-09-04

Professional Organization Advertisement To Date

2019-09-11

Job Search Website From Date

2019-09-04

Job Search Website To Date

2019-09-11

Employee Referral Program From Date

2020-01-01 08:19:03

Employee Referral Program To Date

2020-01-01 08:19:03

Local Ethnic Paper From Date

2019-09-13

Local Ethnic Paper To Date

2019-09-13

Radio/TV Ad From Date

2020-01-01 08:19:03

Radio/TV Ad To Date

2020-01-01 08:19:03

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

2016

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVENUE

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 Blonairz

Preparer Title

Senior Associate

Preparer Email

lablonairz@balglobal.com

Employer Information Declaration Name

Jen Cummings

Employer Information Declaration Title

Senior Associate Human Resources