Fiscal Year

2020

Case Number

A-20027-11643

Case Status

Certified

Received Date

2020-03-09

Decision Date

2020-07-02

Refile

N

Original File Date

2020-01-01 08:33:56

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

12970

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

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

P10019032814115

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

63170.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-07-22

PW Expiration Date

2020-06-30

Wage Offer From

82888.00

Wage Offer To

0.00

Average Salary

82888.00

Wage Unit of Pay

Year

Worksite Address 1

40 Technology Way

Worksite Address 2

Worksite City

West Greenwich

Worksite City Slug

west-greenwich

Worksite State

RHODE ISLAND

Worksite Postal Code

2817

Job Title

Sr Associate, Regulatory Affairs - CMC

Job Title Slug

sr-associate-regulatory-affairs-cmc

Minimum Education

Master's

Major Field of Study

See H.14

Required Training

N

Required Experience

N

Required Experience Months

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

2

Accept Foreign Education

Y

Accept Alternative Occupation

N

Accept Alternative Occupation Months

Accept Alternative Job Title

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Masters degree in Regulatory Affairs, or a related field. OR Bachelors degree in Regulatory Affairs, or a relatedbr field plus two years of related working experience. Must have experience with Organizing and preparing CMCbr preapproval amendments and postmarket supplements for submissions to the FDA; Drafting CMC section ofbr annual reports for specific products to comply with FDA regulations; Completing respective submissions to thebr FDA by compiling data and information utilizing Excellence in Product Information and Collaboration, Insightbr Viewer, and InSight Manager for Registrations; Conducting proofread for accuracy and formatting of submissionbr drafts to ensure compliance to FDA regulations; Managing regulatory assessments of change controls,br deviations, corrective and preventive actions in the change control management systems to ensure compliancebr with FDAs postmarketing requirements and commitments; and Participating in meetings to construct specificbr regulatory strategies impacting business products. Any suitable combination of education, training, orbr 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

2019-10-21

SWA Job Order End Date

2019-11-20

Sunday Edition Newspaper

Y

First Newspaper Name

Providence Journal

First Advertisement Start Date

2019-11-17

Second Newspaper Ad Name

Providence Journal

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-11-24

Employer Website From Date

2020-01-01 08:33:56

Employer Website To Date

2020-01-01 08:33:56

Professional Organization Ad From Date

2019-11-12

Professional Organization Advertisement To Date

2019-11-19

Job Search Website From Date

2019-11-12

Job Search Website To Date

2019-11-19

Employee Referral Program From Date

2020-01-01 08:33:56

Employee Referral Program To Date

2020-01-01 08:33:56

Local Ethnic Paper From Date

2019-11-15

Local Ethnic Paper To Date

2019-11-21

Radio/TV Ad From Date

2020-01-01 08:33:56

Radio/TV Ad To Date

2020-01-01 08:33:56

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 Bloniarz

Preparer Title

Senior Associate

Preparer Email

labloniarz@balglobal.com

Employer Information Declaration Name

Jen Cummings

Employer Information Declaration Title

Senior Associate Human Resources