Fiscal Year

2021

Case Number

A-20233-90342

Case Status

Certified

Received Date

2020-09-10

Decision Date

2021-04-21

Refile

N

Original File Date

2021-01-01 09:15:16

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

CELGENE CORPORATION

Employer Name Slug

celgene-corporation

Employer Address 1

86 MORRIS AVENUE

Employer Address 2

Employer City

SUMMIT

Employer City Slug

summit

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

7901

Employer Phone

9086732009

Employer Number of Employees

3700

Employer Year Commenced Business

1986

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Barbara Colvin

Employer Contact Address 1

86 MORRIS AVENUE

Employer Contact Address 2

Employer Contact City

SUMMIT

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

7901

Employer Contact Phone

908-673-2009

Employer Contact Email

bcolvin@celgene.com

Agent Attorney Name

Lauren E Randle

Agent Attorney Firm Name

Berry Appleman Leiden LLP

Agent Attorney Phone

(469) 290-9685

Agent Attorney Address 1

10100 Katy Freeway

Agent Attorney Address 2

Suite 600

Agent Attorney City

Houston

Agent Attorney State/Province

TEXAS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

77043

Agent Attorney Email

lrandle@balglobal.com

PW Track Number

P10019304120330

PW SOC Code

17-2111

PW SOC Title

Health and Safety Engineers, Except Mining Safety Engineers and Inspectors

PW Skill Level

Level IV

PW Wage

121098.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-02-27

PW Expiration Date

2020-06-30

Wage Offer From

138500.00

Wage Offer To

0.00

Average Salary

138500.00

Wage Unit of Pay

Year

Worksite Address 1

86 Morris Avenue

Worksite Address 2

Worksite City

Summit

Worksite City Slug

summit

Worksite State

NEW JERSEY

Worksite Postal Code

7901

Job Title

Senior Manager, Safety Science

Job Title Slug

senior-manager-safety-science

Minimum Education

Bachelor's

Major Field of Study

PHARMACEUTICAL SCIENCES OR BIOTECHNOLOGY, OR RELATED DISCIPLINE

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

PHARMACEUTICAL SCIENCES OR BIOTECHNOLOGY, OR RELATED DISCIPLINE

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

See H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

BACHELORS DEGREE OR EQUIVALENT IN PHARMACEUTICAL SCIENCES OR BIOTECHNOLOGY, OR RELATED DISCIPLINE, WITH 5 YEARS OF PROGRESSIVE AND POST BACCALAUREATE WORK EXPERIENCE INbr br 1. SAFETY, CLINICAL DEVELOPMENT, AND OPERATIONS;br 2. ADHOC REGULATORY SAFETY REQUESTS AND PREPARATION;br 3. DRUG SAFETY TOPIC REVIEWSAFETY INVESTIGATIVE WRITING, INTEGRATING, ANALYZING, INTERPRETING AND SUMMARIZING CLINICAL TRIAL AND POSTbr MARKETING SAFETY DATA RETRIEVED FROM THE GLOBAL SAFETY DATABASE IN THE FORMAT OF LISTINGS AND TABULATIONS;br 4. COMPILING CLINICAL TRIAL DATA IN THE FORMAT OF LISTINGS AND TABULATIONS;br 5. MEDICAL TERMINOLOGY SUCH AS THAT WHICH IS DESCRIBED IN MEDICAL LITERATURE AND INFORMATION PROVIDED IN ADVERSE EVENT REPORTS FROMbr HEALTHCARE PROVIDERS;br 6. SUMMARIZING SUCH INFORMATION IN AGGREGATE SAFETY REPORTS;br 7. USING DOCUMENT MANAGEMENT SYSTEMS SUCH AS ESUB LIVE LINK WHICH IS USED FOR REVIEW, APPROVAL AND STORAGE OF REGULATORY DOCUMENTSbr INCLUDING AGGREGATE SAFETY REPORTS;br 8. APPLICATION OF PHARMACOVIGILANCE PRINCIPLES AND INTERPRETING AND PRESENTING CLINICAL AND POST MARKETING DATA;br 9. ABILITY TO MEET REGULATORY DEADLINES CONFIRMED BY REGULATORY AFFAIRS;br 10. CLINICAL TRIALS DRUG DEVELOPMENT INCLUDING DRUG DEVELOPMENT IN PHASE I, II, III CLINICAL TRIALS; OVERALL DRUG APPROVAL PROCESS;br 11. APPLYING REGULATORY REQUIREMENTS SET BY THE UNITED STATES FOOD AND DRUG ADMINISTRATIONS FDA, EUROPEAN MEDICINES AGENCYS EMAbr REGULATIONS AND GUIDELINES, THE INTERNATIONAL CONFERENCE ON HARMONIZATION ICH GUIDELINES;br 12. UNDERSTANDING OF THE GLOBAL SAFETY ENVIRONMENT, INCLUDING USE OF INTERNATIONAL REGULATIONS AND GUIDANCE DOCUMENTS;br 13. UNDERSTANDING OF SAFETY DATA CAPTURE IN THE CLINICAL TRIAL AND POST MARKETING CT PM SETTINGS;br 14. SAFETY DATABASE INPUT AND OUTPUT TECHNOLOGY INCLUDING ARISG AND BUSINESS OBJECTS; INTERPRETING PRESENTING AGGREGATE SAFETY DATA;br 15. COMMERCIAL DRUG INDUSTRY; CLINICAL KNOWLEDGE OF THERAPEUTIC AREA PATIENT POPULATIONS DRUG CLASSES;br 16. ABILITY TO REVIEW AND ACCURATELY SUMMARIZE SAFETY DATA THAT IS RETRIEVED FROM THE SAFETY DATABASE IN ORDER TO PREPARE ACCURATE SIGNALbr AND RISK SECTIONS OF AGGREGATE SAFETY REPORTS IN A TIMELY MANNER.

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

2020-03-25

SWA Job Order End Date

2020-04-29

Sunday Edition Newspaper

Y

First Newspaper Name

The Star Ledger

First Advertisement Start Date

2020-03-29

Second Newspaper Ad Name

The Star Ledger

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-04-05

Employer Website From Date

2021-01-01 09:15:16

Employer Website To Date

2021-01-01 09:15:16

Professional Organization Ad From Date

2021-01-01 09:15:16

Professional Organization Advertisement To Date

2021-01-01 09:15:16

Job Search Website From Date

2020-03-31

Job Search Website To Date

2020-04-06

Employee Referral Program From Date

2021-01-01 09:15:16

Employee Referral Program To Date

2021-01-01 09:15:16

Local Ethnic Paper From Date

2020-04-02

Local Ethnic Paper To Date

2020-04-02

Radio/TV Ad From Date

2020-04-01

Radio/TV Ad To Date

2020-04-01

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

BIOTECHNOLOGY

Foreign Worker Years of Education Completed

2009

Foreign Worker Institution of Education

POLYTECHNIC INSTITUTE OF NEW YORK UNIVERSITY

Foreign Worker Education Institution Address 1

6 METROTECH CENTER

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

Lauren E Randle

Preparer Title

Associate Attorney

Preparer Email

lrandle@balglobal.com

Employer Information Declaration Name

Barbara Colvin

Employer Information Declaration Title

Manager, Global Mobility