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Case Number: A-21294-61598

Fiscal year: 2022

Fiscal Year

2022

Case Number

A-21294-61598

Case Status

Certified

Received Date

2021-11-03

Decision Date

2022-05-24

Refile

N

Original File Date

2022-01-01 11:32:06

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

REGENERON PHARMACEUTICALS, INC.

Employer Name Slug

regeneron-pharmaceuticals-inc

Employer Address 1

777 OLD SAW MILL RIVER ROAD

Employer Address 2

Employer City

TARRYTOWN

Employer City Slug

tarrytown

Employer State

NEW YORK

Employer State Slug

new-york

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

10591

Employer Phone

914-847-3570

Employer Number of Employees

9123

Employer Year Commenced Business

1988

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Tanya Correa

Employer Contact Address 1

777 Old Saw Mill River Road

Employer Contact Address 2

Employer Contact City

Tarrytown

Employer Contact State/Province

NEW YORK

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

10591

Employer Contact Phone

(914) 847-3570

Employer Contact Email

tanya.correa@regeneron.com

Agent Attorney Name

Chelsea D Germak

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy, LLP

Agent Attorney Phone

7328625194

Agent Attorney Address 1

90 Matawan Road

Agent Attorney Address 2

4th Floor

Agent Attorney City

Matawan

Agent Attorney State/Province

NEW JERSEY

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

7747

Agent Attorney Email

CGermak@fragomen.com

PW Track Number

P10020347955679

PW SOC Code

19-4021

PW SOC Title

Biological Technicians

PW Skill Level

Level IV

PW Wage

62670.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-05-06

PW Expiration Date

2021-08-04

Wage Offer From

78300.00

Wage Offer To

101700.00

Average Salary

90000.00

Wage Unit of Pay

Year

Worksite Address 1

110 Allen Road

Worksite Address 2

Worksite City

Basking Ridge

Worksite City Slug

basking-ridge

Worksite State

NEW JERSEY

Worksite Postal Code

7920

Job Title

Senior Clinical Documentation Associate

Job Title Slug

senior-clinical-documentation-associate

Minimum Education

Bachelor's

Major Field of Study

Pharmacy, Toxicology, or related field

Required Training

N

Required Experience

Y

Required Experience Months

60

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

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

5 yrs exp in biotech, pharma, or healthrltd industry

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Qualified applicants will have a Bachelors degree in Pharmacy, Toxicology, or related field, and 5 years of experience in the Biotechnology, Pharmaceutical, or HealthRelated industry. Experience must include working knowledge of TMF Reference model and processing of documentation into the eTMF system; working knowledge of ICHGCP R2, BIMO and EMA Guidelines; ability to create the TMF plan and the Study Inventory List; Clinical Veeva Vault and its various functionalities; ability to run reports in Qliksense data analysis tool and analyze metrics for study teams action; analyzing various TMF Health scores and presentingescalating it to leadership team; continuous business improvement initiatives along with change management; Expected Document List in Veeva; managing Inspection Readiness Reviews or quality reviews towards an active and Inspection Ready TMF; collaboration with eTMF team for Veeva functionality enhancement and optimization; developing trainings for various TMF processes; and skills with Microsoft Applications such as Excel, Word, Powerpoint, Visio, and Project.

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

2021-07-21

SWA Job Order End Date

2021-08-21

Sunday Edition Newspaper

Y

First Newspaper Name

Newark Star Ledger

First Advertisement Start Date

2021-08-01

Second Newspaper Ad Name

Newark Star Ledger

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-08-08

Employer Website From Date

2021-08-02

Employer Website To Date

2021-08-16

Professional Organization Ad From Date

2022-01-01 11:32:06

Professional Organization Advertisement To Date

2022-01-01 11:32:06

Job Search Website From Date

2021-08-02

Job Search Website To Date

2021-08-09

Employee Referral Program From Date

2022-01-01 11:32:06

Employee Referral Program To Date

2022-01-01 11:32:06

Local Ethnic Paper From Date

2021-08-04

Local Ethnic Paper To Date

2021-08-04

Radio/TV Ad From Date

2022-01-01 11:32:06

Radio/TV Ad To Date

2022-01-01 11:32:06

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

TOXICOLOGY

Foreign Worker Years of Education Completed

2011

Foreign Worker Institution of Education

ST. JOHNS UNIVERSITY

Foreign Worker Education Institution Address 1

8000 UTOPIA PARKWAY

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

QUEENS

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

11439

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Chelsea D Germak

Preparer Title

Senior Associate

Preparer Email

CGermak@fragomen.com

Employer Information Declaration Name

Tanya Correa

Employer Information Declaration Title

Senior Manager, HR Global Services