Fiscal Year

2020

Case Number

A-19191-28653

Case Status

Certified-Expired

Received Date

2019-09-30

Decision Date

2019-12-16

Refile

N

Original File Date

2020-01-01 07:33:59

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ERNST YOUNG U.S. LLP

Employer Name Slug

ernst-young-us-llp

Employer Address 1

200 PLAZA DRIVE

Employer Address 2

Employer City

SECAUCUS

Employer City Slug

secaucus

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

7094

Employer Phone

201-872-2200

Employer Number of Employees

40000

Employer Year Commenced Business

1989

NAICS Code

541211

FW Ownership Interest

N

Employer Contact Name

Sunday D Rubenstein

Employer Contact Address 1

200 Plaza Drive

Employer Contact Address 2

Employer Contact City

Secaucus

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

7094

Employer Contact Phone

201-872-2200 2899

Employer Contact Email

Sunday.Rubenstein@ey.com

Agent Attorney Name

Joo Young Seo

Agent Attorney Firm Name

EY Law LLP

Agent Attorney Phone

416 943 3548

Agent Attorney Address 1

100 Adelaide Street West

Agent Attorney Address 2

Floor 31

Agent Attorney City

Toronto

Agent Attorney State/Province

Ontario

Agent Attorney Country

CANADA

Agent Attorney Postal Code

M5H 0B3

Agent Attorney Email

eyusperm@ca.ey.com

PW Track Number

P10019023124962

PW SOC Code

13-1111

PW SOC Title

Management Analysts

PW Skill Level

Level IV

PW Wage

140046.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-05-23

PW Expiration Date

2019-08-21

Wage Offer From

178000.00

Wage Offer To

0.00

Average Salary

178000.00

Wage Unit of Pay

Year

Worksite Address 1

99 Wood Avenue South

Worksite Address 2

Worksite City

Iselin

Worksite City Slug

iselin

Worksite State

NEW JERSEY

Worksite Postal Code

8830

Job Title

Risk Advisor, RCTS (Life Society Quality & Compliance) Senior Manager

Job Title Slug

risk-advisor-rcts-life-society-quality-compliance-senior-manager

Minimum Education

Bachelor's

Major Field of Study

Pharmacy

Required Training

N

Required Experience

Y

Required Experience Months

96

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Biotech., Bioengi., Medi Tech., Bio, Chem, Engg, Bus. or a related field

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

7

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

96

Accept Alternative Job Title

Any in which the required experience is gained.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Must have a Bachelors degree in Pharmacy, Biotechnology, Bioengineering, Medical Technology, Biology, Chemistry, Engineering, Business or a related field and 8 years of related work experience, of which 5 years must be progressive, postbaccalaureate. Alternatively, will accept a Masters degree in Pharmacy, Biotechnology, Bioengineering, Medical Technology, Biology, Chemistry, Engineering, Business or a related field and 7 years of related work experience.br br Must have 7 years of experience working in Life Sciences sector advisory consulting andor working at a Life Sciences organization in corporate risk, compliance, or quality.br br Must have 7 years of experience in risk measurement and quantification techniques.br br Must have 6 years of experience in all of the followingbr Clinical trials, GCP requirements and regulatory experience at a CRO or consulting organizationbr Leading IT validation programsbr Quality management system QMS experience working with applicable regulatory requirements such as 21 CFR Parts 11, 210, 211, 610, 820 or HIPPAbr Project management, including accountability for schedules, deliverables, priorities and dependencies, progress updates, team management, and client servicebr Drafting proposals and leading bid defenses for new pursuits across multiple clientsbr br Must have 4 years of experience developing cGxP audit plans, assessments and reports.br br Must have 4 years of experience in at least one of the followingbr Quality and regulatory operations and developing, improving or remediating Quality management systems for Life Sciences organizations, performing or managing responses to health authority e.g. FDA observations, implementing LIMS and other QMS systemsbr Designing continuous process improvement frameworks, tools and templates, and ability to conduct root cause assessment and define corrective and preventative actions CAPA in GxP environmentbr Computerized System Validation CSV and testing in a validated environment with reallife knowledge of Software Development Life Cycle requirements, different agile, waterfall, and testing automation i.e. Quality Center, ValGenesis and issues tracking tools i.e. Atlassian tool sets JIRAbr br Must have 5 years of experience with endtoend management of clinical trials, including study design, study coordination, patient data acquisition and management; close out; external data management, regulatory reporting and riskbased monitoring.br br Must have 4 years of experience in Risk analytics and modelling experience e.g. scenario analysis, risk optimization, value at risk.br br Must have 4 years of experience managing Life Sciences Quality and Compliance teams.br br Must have a CPACA, CIA, CISA, CMA, RICS APC, PMP or the ability to obtain a certification within one year of hire.br br Requires travel up to 80, to serve client needs.br br Employer will accept any suitable combination of education, training or experience.

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

2019-06-04

SWA Job Order End Date

2019-07-09

Sunday Edition Newspaper

Y

First Newspaper Name

The StarLedger

First Advertisement Start Date

2019-06-09

Second Newspaper Ad Name

The StarLedger

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-06-16

Employer Website From Date

2019-06-04

Employer Website To Date

2019-07-09

Professional Organization Ad From Date

2020-01-01 07:33:59

Professional Organization Advertisement To Date

2020-01-01 07:33:59

Job Search Website From Date

2019-06-05

Job Search Website To Date

2019-07-09

Employee Referral Program From Date

2019-06-04

Employee Referral Program To Date

2019-07-09

Local Ethnic Paper From Date

2020-01-01 07:33:59

Local Ethnic Paper To Date

2020-01-01 07:33:59

Radio/TV Ad From Date

2020-01-01 07:33:59

Radio/TV Ad To Date

2020-01-01 07:33:59

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

Bachelor's

Foreign Worker Information: Major

BIOTECHNOLOGY

Foreign Worker Years of Education Completed

2009

Foreign Worker Institution of Education

UNIVERSITY OF RAJASTHAN

Foreign Worker Education Institution Address 1

JLN MARG

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

JAIPUR

Foreign Worker Education Institution State/Province

RAJASTHAN

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

302004

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Joo Young Seo

Preparer Title

Attorney

Preparer Email

eyusperm@ca.ey.com

Employer Information Declaration Name

Mary JoAnh Tsotsoros Pitts

Employer Information Declaration Title

Supervising Associate Associate Director, ATT