Fiscal Year

2022

Case Number

A-21232-34155

Case Status

Certified-Expired

Received Date

2021-09-20

Decision Date

2022-04-04

Refile

N

Original File Date

2022-01-01 11:12:05

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

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@bal.com

PW Track Number

P10021007001367

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level III

PW Wage

128752.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-05-18

PW Expiration Date

2021-08-16

Wage Offer From

128752.00

Wage Offer To

0.00

Average Salary

128752.00

Wage Unit of Pay

Year

Worksite Address 1

One Amgen Center Drive

Worksite Address 2

Worksite City

Thousand Oaks

Worksite City Slug

thousand-oaks

Worksite State

CALIFORNIA

Worksite Postal Code

91320

Job Title

US Regulatory Lead

Job Title Slug

us-regulatory-lead

Minimum Education

Doctorate

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

Master's

Accept Alternative Combination Education Years

3

Accept Foreign Education

Y

Accept Alternative Occupation

N

Accept Alternative Occupation Months

Accept Alternative Job Title

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

DOCTORATE IN PHARMACY OR A RELATED FIELD, AND COMPLETION OF A UNIVERSITYLEVEL COURSE, RESEARCH PROJECT, INTERNSHIP, THESIS, OR ONE YEAR OF EXPERIENCE INVOLVING THE FOLLOWINGbr 1. UTILIZING SPECIALIZED KNOWLEDGE OF ANATOMY AND PHYSIOLOGY, PATHOPHYSIOLOGY, MEDICINAL CHEMISTRY, PHARMACOLOGY, PHARMACOKINETICS ANDbr PHARMACOTHERAPY RELATED TO THE MANAGEMENT OF DISEASES, INCLUDING HEMATOLOGICAL AND ONCOLOGIC DISEASES TO SUPPORT DRUG DEVELOPMENTbr STRATEGY AND COMMUNICATIONS WITH REGULATORY AUTHORITIES;br 2. COMPLETING US FDA SUBMISSIONS, REGULATORY COMPLIANCE FOR PHARMACEUTICALS, AND CLINICAL TRIAL DESIGN REGULATORY REQUIREMENTS;br 3. UNDERSTANDING SIMILARITIES AND DIFFERENCES IN REGIONAL REGULATORY REQUIREMENTS TO FACILITATE STRATEGIC DISCUSSION WITH U.S. FDA REGARDINGbr THE DEVELOPMENT AND AUTHORIZATION OF SAFE AND EFFECTIVE PRODUCTS;br 4. UNDERSTANDING OF PEDIATRIC DRUG DEVELOPMENT REQUIREMENTS AT THE FOOD AND DRUG ADMINISTRATION;br 5. UNDERSTANDING OF US AND GLOBAL LABELING REQUIREMENTS TO SUCCESSFULLY MANAGE THE DEVELOPMENT OF THE REGIONAL PRODUCT LABEL;br ORbr MASTERS DEGREE IN PHARMACY OR A RELATED FIELD, AND 3 YEARS OF EXPERIENCE INVOLVING THE FOLLOWINGbr 1. UTILIZING SPECIALIZED KNOWLEDGE OF ANATOMY AND PHYSIOLOGY, PATHOPHYSIOLOGY, MEDICINAL CHEMISTRY, PHARMACOLOGY, PHARMACOKINETICS ANDbr PHARMACOTHERAPY RELATED TO THE MANAGEMENT OF DISEASES, INCLUDING HEMATOLOGICAL AND ONCOLOGIC DISEASES TO SUPPORT DRUG DEVELOPMENTbr STRATEGY AND COMMUNICATIONS WITH REGULATORY AUTHORITIES;br 2. COMPLETING US FDA SUBMISSIONS, REGULATORY COMPLIANCE FOR PHARMACEUTICALS, AND CLINICAL TRIAL DESIGN REGULATORY REQUIREMENTS;br 3. UNDERSTANDING SIMILARITIES AND DIFFERENCES IN REGIONAL REGULATORY REQUIREMENTS TO FACILITATE STRATEGIC DISCUSSION WITH U.S. FDA REGARDINGbr THE DEVELOPMENT AND AUTHORIZATION OF SAFE AND EFFECTIVE PRODUCTS;br 4. UNDERSTANDING OF PEDIATRIC DRUG DEVELOPMENT REQUIREMENTS AT THE FOOD AND DRUG ADMINISTRATION;br 5. UNDERSTANDING OF US AND GLOBAL LABELING REQUIREMENTS TO SUCCESSFULLY MANAGE THE DEVELOPMENT OF THE REGIONAL PRODUCT LABEL;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

2021-06-03

SWA Job Order End Date

2021-07-06

Sunday Edition Newspaper

Y

First Newspaper Name

Los Angeles Daily News

First Advertisement Start Date

2021-06-20

Second Newspaper Ad Name

Los Angeles Daily News

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-06-27

Employer Website From Date

2022-01-01 11:12:05

Employer Website To Date

2022-01-01 11:12:05

Professional Organization Ad From Date

2021-06-18

Professional Organization Advertisement To Date

2021-06-25

Job Search Website From Date

2021-06-18

Job Search Website To Date

2021-06-25

Employee Referral Program From Date

2022-01-01 11:12:05

Employee Referral Program To Date

2022-01-01 11:12:05

Local Ethnic Paper From Date

2021-06-24

Local Ethnic Paper To Date

2021-06-24

Radio/TV Ad From Date

2022-01-01 11:12:05

Radio/TV Ad To Date

2022-01-01 11:12:05

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

CANADA

Foreign Worker Birth Country

CANADA

Class of Admission

H-1B

Foreign Worker Education

Doctorate

Foreign Worker Information: Major

PHARMACY

Foreign Worker Years of Education Completed

2017

Foreign Worker Institution of Education

FAIRLEIGH DICKINSON SCHOOL OF PHARMACY

Foreign Worker Education Institution Address 1

230 PARK AVENUE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

FLORHAM PARK

Foreign Worker Education Institution State/Province

NJ

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

7932

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 Cummings

Employer Information Declaration Title

HR Representative