Fiscal Year

2024

Case Number

A-22343-71047

Case Status

Certified-Expired

Received Date

2023-03-17

Decision Date

2024-03-29

Refile

N

Original File Date

2024-01-01 01:04:30

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Jazz Pharmaceuticals, Inc.

Employer Name Slug

jazz-pharmaceuticals-inc

Employer Address 1

3170 Porter Dr

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

6504963777

Employer Number of Employees

1300

Employer Year Commenced Business

2003

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Candice Taylor

Employer Contact Address 1

3170 Porter Dr

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

7606838846

Employer Contact Email

candice.taylor@jazzpharma.com

Agent Attorney Name

Julia Macri

Agent Attorney Firm Name

Jackson Hertogs LLP

Agent Attorney Phone

(415) 986-4559

Agent Attorney Address 1

909 Montgomery St

Agent Attorney Address 2

Ste. 200

Agent Attorney City

San Francisco

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

94133

Agent Attorney Email

jmacri@jackson-hertogs.com

PW Track Number

P10022049912538

PW SOC Code

13-1041.07

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

82534.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-09-27

PW Expiration Date

2023-06-30

Wage Offer From

110100.00

Wage Offer To

0.00

Average Salary

110100.00

Wage Unit of Pay

Year

Worksite Address 1

3170 Porter Drive

Worksite Address 2

Worksite City

Palo Alto

Worksite City Slug

palo-alto

Worksite State

CALIFORNIA

Worksite Postal Code

94304

Job Title

Senior Associate, Publishing, Global Regulatory Operations

Job Title Slug

senior-associate-publishing-global-regulatory-operations

Minimum Education

Bachelor's

Major Field of Study

Healthcare Administration

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Pharmacology, or related field

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

36

Accept Alternative Job Title

Regulatory Operations Associate, Regulatory Publisher, or related occupation

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must have at least 1 year of prior work experience in each of the followingbr 1. Document creating and publishing software MS WordExcel, Adobe Acrobat and managing documents through a 21CFR Part 11 compliant EDMS system for regulatory submissions.br 2. Preparing and filing amendments, annual reports and supplements for IND and NDA submissions.br 3. Formatting and publishing Clinical Study Reports, NonClinical Reports, DSUR, IMPDs, and Briefing Books.br 4. Reviewing, validating, and transmitting eCTD submissions.br 5. Creating the necessary submission components including ICH, STF and regional XML files, leaf files, and folder structures within an eCTD publishing tool.br 6. Preparing and submitting regulatory documentation for multiple clinical study protocols and protocol amendments for various products in pre and postmarketing clinical trials Phases IIV.br 7. Ensuring compliant, high quality, timely submissions in accordance with current and emerging Health Authority guidance across multiple regions, including the US and Canada.br Occasional telecommuting permitted

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

2022-10-06

SWA Job Order End Date

2022-11-08

Sunday Edition Newspaper

Y

First Newspaper Name

The Mercury News

First Advertisement Start Date

2022-10-16

Second Newspaper Ad Name

The Mercury News

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-10-23

Employer Website From Date

2024-01-01 01:04:30

Employer Website To Date

2024-01-01 01:04:30

Professional Organization Ad From Date

2024-01-01 01:04:30

Professional Organization Advertisement To Date

2024-01-01 01:04:30

Job Search Website From Date

2022-10-14

Job Search Website To Date

2022-10-21

Employee Referral Program From Date

2022-10-06

Employee Referral Program To Date

2022-10-20

Local Ethnic Paper From Date

2022-10-21

Local Ethnic Paper To Date

2022-10-21

Radio/TV Ad From Date

2024-01-01 01:04:30

Radio/TV Ad To Date

2024-01-01 01:04:30

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

HEALTHCARE ADMINISTRATION

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

UNIVERSITY OF NEW HAVEN

Foreign Worker Education Institution Address 1

300 BOSTON POST RD

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

WEST HAVEN

Foreign Worker Education Institution State/Province

CT

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

6516

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Julia Macri

Preparer Title

Attorney at Law

Preparer Email

jmacri@jackson-hertogs.com

Employer Information Declaration Name

Candice Taylor

Employer Information Declaration Title

People Operations Analyst