Fiscal Year

2020

Case Number

A-19213-38946

Case Status

Certified-Expired

Received Date

2019-08-07

Decision Date

2019-10-09

Refile

N

Original File Date

2020-01-01 07:46:16

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

JAZZ PHARMACEUTICALS

Employer Name Slug

jazz-pharmaceuticals

Employer Address 1

3170 PORTER DRIVE

Employer Address 2

Employer City

PALO ALTO

Employer City Slug

palo-alto

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

94304

Employer Phone

650-496-3777

Employer Number of Employees

780

Employer Year Commenced Business

2003

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Aaron Atsin

Employer Contact Address 1

3170 Porter Drive

Employer Contact Address 2

Employer Contact City

Palo Alto

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

94304

Employer Contact Phone

650-496-2850

Employer Contact Email

Aaron.Atsin@jazzpharma.com

Agent Attorney Name

Norman C Plotkin

Agent Attorney Firm Name

Jackson Hertogs LLP

Agent Attorney Phone

(415) 986-4559

Agent Attorney Address 1

201 Mission Street, Suite 700

Agent Attorney Address 2

Agent Attorney City

San Francisco

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

94105

Agent Attorney Email

nplotkin@jackson-hertogs.com

PW Track Number

P1001829027058

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level II

PW Wage

92248.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-02-20

PW Expiration Date

2019-06-30

Wage Offer From

112150.00

Wage Offer To

0.00

Average Salary

112150.00

Wage Unit of Pay

Year

Worksite Address 1

1 Commerce Square

Worksite Address 2

2005 Market St., Suite 2100

Worksite City

Philadelphia

Worksite City Slug

philadelphia

Worksite State

PENNSYLVANIA

Worksite Postal Code

19103

Job Title

Manager, Regulatory Affairs Strategy

Job Title Slug

manager-regulatory-affairs-strategy

Minimum Education

Master's

Major Field of Study

Regulatory Affairs

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Drug Regulatory Affairs, or a related field

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

24

Accept Alternative Job Title

Regulatory Affairs Associate or related occupation

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must have at least 1 year of prior work in each of the following 1. Supporting the preparation and filing of U.S. pharmaceutical regulatory applications IND, NDA, or BLA 2. Strategic application of regulations and guidelines for drug development at IND and NDABLA stages 3. Electronic Common Technical Document eCTD submissions with ability to create content 4. Development Safety Update Reports DSUR, Periodic Adverse Experience Reports PAER, Periodic Safety Update Reports PSUR, Periodic BenefitRisk Evaluation Reports PBRER, and 120Day Safety Update Reports 5. Protocol amendments including new protocol, change in protocol and new investigator, change in contacts, Structured Product Labeling SPL, Clinical Safety Reports CSR, Briefing Packages for Type A, B, or C. Any suitable combination of education, training, andor 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

2019-02-28

SWA Job Order End Date

2019-04-08

Sunday Edition Newspaper

Y

First Newspaper Name

Philadelphia Inquirer

First Advertisement Start Date

2019-03-10

Second Newspaper Ad Name

Philadelphia Inquirer

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-03-17

Employer Website From Date

2019-03-05

Employer Website To Date

2019-03-11

Professional Organization Ad From Date

2020-01-01 07:46:16

Professional Organization Advertisement To Date

2020-01-01 07:46:16

Job Search Website From Date

2020-01-01 07:46:16

Job Search Website To Date

2020-01-01 07:46:16

Employee Referral Program From Date

2019-03-12

Employee Referral Program To Date

2019-03-27

Local Ethnic Paper From Date

2019-03-11

Local Ethnic Paper To Date

2019-03-11

Radio/TV Ad From Date

2020-01-01 07:46:16

Radio/TV Ad To Date

2020-01-01 07:46:16

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

DRUG REGULATORY AFFAIRS

Foreign Worker Years of Education Completed

2012

Foreign Worker Institution of Education

LONG ISLAND UNIVERSITY

Foreign Worker Education Institution Address 1

1 UNIVERSITY PLAZA

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BROOKLYN

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

11201

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Norman C Plotkin

Preparer Title

Partner

Preparer Email

nplotkin@jackson-hertogs.com

Employer Information Declaration Name

Dave Kuo

Employer Information Declaration Title

Head of HR Operations, Human Resources