Fiscal Year

2024

Case Number

A-23093-22022

Case Status

Certified

Received Date

2023-04-17

Decision Date

2024-05-13

Refile

N

Original File Date

2024-01-01 01:20:56

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ORGANON, LLC

Employer Name Slug

organon-llc

Employer Address 1

30 HUDSON STREET, FLOOR 33

Employer Address 2

Employer City

JERSEY CITY

Employer City Slug

jersey-city

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

7302

Employer Phone

551-655-6047

Employer Number of Employees

1666

Employer Year Commenced Business

2020

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Kevin Vega

Employer Contact Address 1

30 Hudson Street, Floor 33

Employer Contact Address 2

Employer Contact City

Jersey City

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

7302

Employer Contact Phone

551-655-6047

Employer Contact Email

kevin.vega@organon.com

Agent Attorney Name

Ludka Zimovcak

Agent Attorney Firm Name

NPZ Law Group, P.C.

Agent Attorney Phone

2016700006

Agent Attorney Address 1

487 Goffle Road

Agent Attorney Address 2

Visaserve Plaza

Agent Attorney City

Ridgewood

Agent Attorney State/Province

NEW JERSEY

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

7450

Agent Attorney Email

ludka_zimovcak@visaserve.com

PW Track Number

P10022027858255

PW SOC Code

13-1041.07

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

66414.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-09-26

PW Expiration Date

2023-06-30

Wage Offer From

66414.00

Wage Offer To

0.00

Average Salary

66414.00

Wage Unit of Pay

Year

Worksite Address 1

1180 Church Road, Suite 1

Worksite Address 2

Worksite City

Lansdale

Worksite City Slug

lansdale

Worksite State

PENNSYLVANIA

Worksite Postal Code

19446

Job Title

Sr. Scientist, Regulatory Affairs Liaison

Job Title Slug

sr-scientist-regulatory-affairs-liaison

Minimum Education

Master's

Major Field of Study

REGULATORY AFFAIRS

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

N

Accept Alternative Occupation

N

Accept Alternative Occupation Months

Accept Alternative Job Title

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Must have a Masters degree in Regulatory Affairs. Must have 2 years experience in regulatory affairs in a pharmaceutical company andor CRO in pharmaceutical industry. Must have experience in compilation, preparation, strategy, review and submission of regulatory submissions for marketing authorizations in various global markets. Must have thorough knowledge of clinical research documentation such as ICF, FDA 1571, 1572; quality and clinical regulations such as CFR Title 21, ICH, WHO guidelines, GMPs, GLPs and GCPs; skills such as Excel, PowerPoint, and SharePoint. 40 hrs per week 9am5pm. Must have proof of legal authority to work in the United States.

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

2022-11-29

SWA Job Order End Date

2023-01-20

Sunday Edition Newspaper

Y

First Newspaper Name

The Philadelphia Inquirer

First Advertisement Start Date

2023-01-08

Second Newspaper Ad Name

The Philadelphia Inquirer

Second Advertisement Type

Newspaper

Second Ad Start Date

2023-01-15

Employer Website From Date

2022-10-25

Employer Website To Date

2023-03-09

Professional Organization Ad From Date

2024-01-01 01:20:56

Professional Organization Advertisement To Date

2024-01-01 01:20:56

Job Search Website From Date

2023-01-20

Job Search Website To Date

2023-01-27

Employee Referral Program From Date

2024-01-01 01:20:56

Employee Referral Program To Date

2024-01-01 01:20:56

Local Ethnic Paper From Date

2023-01-11

Local Ethnic Paper To Date

2023-01-11

Radio/TV Ad From Date

2024-01-01 01:20:56

Radio/TV Ad To Date

2024-01-01 01:20:56

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

2014

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVE, 405 ELL HALL

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

Ludka Zimovcak

Preparer Title

Managing Attorney

Preparer Email

ludka_zimovcak@visaserve.com

Employer Information Declaration Name

Kevin Vega

Employer Information Declaration Title

Employment and Benefits Legal Specialist