Fiscal Year

2024

Case Number

A-22206-94432

Case Status

Denied

Received Date

2022-08-09

Decision Date

2023-12-08

Refile

N

Original File Date

2024-01-01 00:24:02

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ALKERMES, INC.

Employer Name Slug

alkermes-inc

Employer Address 1

852 WINTER STREET

Employer Address 2

Employer City

WALTHAM

Employer City Slug

waltham

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2451

Employer Phone

781-609-6953

Employer Number of Employees

2000

Employer Year Commenced Business

1987

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Peter Mello

Employer Contact Address 1

852 Winter Street

Employer Contact Address 2

Employer Contact City

Waltham

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2451

Employer Contact Phone

(781) 609-6510

Employer Contact Email

peter.mello@alkermes.com

Agent Attorney Name

Kevin J Fitzgerald

Agent Attorney Firm Name

Foley Hoag LLP

Agent Attorney Phone

(617) 832-1122

Agent Attorney Address 1

155 Seaport Boulevard

Agent Attorney Address 2

Ste. 1600

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2210

Agent Attorney Email

kfitzgerald@foleyhoag.com

PW Track Number

P10021161386372

PW SOC Code

17-2199

PW SOC Title

Engineers, All Other

PW Skill Level

Level IV

PW Wage

162032.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-02-11

PW Expiration Date

2022-06-30

Wage Offer From

162250.00

Wage Offer To

0.00

Average Salary

162250.00

Wage Unit of Pay

Year

Worksite Address 1

852 Winter Street

Worksite Address 2

Worksite City

Waltham

Worksite City Slug

waltham

Worksite State

MASSACHUSETTS

Worksite Postal Code

2451

Job Title

Validation Manager

Job Title Slug

validation-manager

Minimum Education

Bachelor's

Major Field of Study

Comp Sci, Regulatory Information Management, or equiv

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

8

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

120

Accept Alternative Job Title

computer systems validation in pharmaceutical industry,

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

including 5 yrs supporting Enterprise Quality System including ComplianceWire LMS, Veeva Document Management System, TrackWiseTrackWise Digital platform; 3 yrs managing validation documentation in paperless validation system such as ValGenesis and Regulatory publishinglabel management system; and 6 yrs as technical team lead exp can be gained concurrently; knowledge of GxP requirements and FDA regulatory requirements related to manufacture of pharmaceutical products.

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

2022-02-22

SWA Job Order End Date

2022-03-28

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2022-02-27

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-03-06

Employer Website From Date

2022-02-16

Employer Website To Date

2022-03-03

Professional Organization Ad From Date

2024-01-01 00:24:02

Professional Organization Advertisement To Date

2024-01-01 00:24:02

Job Search Website From Date

2024-01-01 00:24:02

Job Search Website To Date

2024-01-01 00:24:02

Employee Referral Program From Date

2022-02-16

Employee Referral Program To Date

2022-03-03

Local Ethnic Paper From Date

2022-03-03

Local Ethnic Paper To Date

2022-03-03

Radio/TV Ad From Date

2024-01-01 00:24:02

Radio/TV Ad To Date

2024-01-01 00:24:02

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

Foreign Worker Years of Education Completed

2012

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVENUE

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

Kevin J Fitzgerald

Preparer Title

Attorney

Preparer Email

kfitzgerald@foleyhoag.com

Employer Information Declaration Name

Peter Mello

Employer Information Declaration Title

Senior Director, Talent Acquisition