Fiscal Year

2020

Case Number

A-19224-43001

Case Status

Certified-Expired

Received Date

2019-08-16

Decision Date

2019-11-06

Refile

N

Original File Date

2020-01-01 07:48:55

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

SANOFI US SERVICES INC.

Employer Name Slug

sanofi-us-services-inc

Employer Address 1

55 CORPORATE DRIVE

Employer Address 2

Employer City

BRIDGEWATER

Employer City Slug

bridgewater

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

8807

Employer Phone

908-981-5500

Employer Number of Employees

13434

Employer Year Commenced Business

2003

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Janet D'Errico

Employer Contact Address 1

1 Research Drive

Employer Contact Address 2

Employer Contact City

Westborough

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

1581

Employer Contact Phone

1 508 871-5715

Employer Contact Email

janet.derrico@sanofi.com

Agent Attorney Name

Ian P BAND

Agent Attorney Firm Name

Hunton Andrews Kurth LLP

Agent Attorney Phone

202-955-1913

Agent Attorney Address 1

Hunton Andrews Kurth LLP

Agent Attorney Address 2

2200 Pennsylvania Avenue, NW

Agent Attorney City

Washington

Agent Attorney State/Province

DISTRICT OF COLUMBIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

20037

Agent Attorney Email

iband@huntonak.com

PW Track Number

P10018337275134

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level II

PW Wage

72446.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-05-20

PW Expiration Date

2019-08-18

Wage Offer From

104915.00

Wage Offer To

155903.00

Average Salary

130409.00

Wage Unit of Pay

Year

Worksite Address 1

153 Second Avenue

Worksite Address 2

Worksite City

Waltham

Worksite City Slug

waltham

Worksite State

MASSACHUSETTS

Worksite Postal Code

2451

Job Title

PV Compliance Manager

Job Title Slug

pv-compliance-manager

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

Y

Accept Alternative Major Field of Study

a life sciences 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

experience coordinating pharmacovigilance activities

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Of total experience required, at least 2 years of experience working in international, crossfunctional team environmentbr br Of total experience required, at least 2 years of experience working with regulatory tools and databases such as PV Monitor or global safety databasesbr br Understanding of international pharmacovigilance regulations updates in corresponding EUFDAbr regulationsinternational guidelines, e.g. ICHCIOMS, as well as understanding of clinical developmentbr methodology and knowledge of clinical trial guidelines GCP and regulationsbr br Ability to identify and anticipate risk of noncompliance in complex environmentbr Ability to effectively communicate complex regulatory situations to subject matter experts and to identify route cause of deviationsbr br br F2 SOC ONETOES Code 131041.07br F3 SOC ONETOES occupational title Regulatory Affairs Specialistsbr br br Minimum Requirements Alternate Requirements Contdbr br At least a Masters degree in regulatory affairs or a life sciences field and 2 years of experience in the job offered, or of experience coordinating pharmacovigilance activities.br br OR any suitable combination of education, training and experience, but no less than a Bachelors degree followed by 5 years of experience as described above.

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

2019-05-07

SWA Job Order End Date

2019-06-17

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2019-05-12

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-05-19

Employer Website From Date

2020-01-01 07:48:55

Employer Website To Date

2020-01-01 07:48:55

Professional Organization Ad From Date

2020-01-01 07:48:55

Professional Organization Advertisement To Date

2020-01-01 07:48:55

Job Search Website From Date

2019-05-13

Job Search Website To Date

2019-06-10

Employee Referral Program From Date

2020-01-01 07:48:55

Employee Referral Program To Date

2020-01-01 07:48:55

Local Ethnic Paper From Date

2020-01-01 07:48:55

Local Ethnic Paper To Date

2020-01-01 07:48:55

Radio/TV Ad From Date

2019-05-18

Radio/TV Ad To Date

2019-05-18

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

2012

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

ATTN OFFICE OF THE REGISTRAR 230271

Foreign Worker Education Institution Address 2

360 HUNTINGTON AVENUE

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

02115-5000

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Ian P BAND

Preparer Title

Attorney

Preparer Email

iband@huntonak.com

Employer Information Declaration Name

Janet L DErrico

Employer Information Declaration Title

Senior US Immigration Specialist