Fiscal Year

2022

Case Number

A-21173-05048

Case Status

Certified-Expired

Received Date

2021-06-22

Decision Date

2021-12-10

Refile

N

Original File Date

2022-01-01 10:34:29

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

VERASTEM, INC.

Employer Name Slug

verastem-inc

Employer Address 1

117 KENDRICK STREET

Employer Address 2

SUITE 500

Employer City

NEEDHAM

Employer City Slug

needham

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2494

Employer Phone

781-292-4200

Employer Number of Employees

47

Employer Year Commenced Business

2010

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Heidi Church

Employer Contact Address 1

117 Kendrick Street

Employer Contact Address 2

Suite 500

Employer Contact City

Needham

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2494

Employer Contact Phone

781-964-3052

Employer Contact Email

hchurch@verastem.com

Agent Attorney Name

Laurie B Riccio

Agent Attorney Firm Name

Costa Riccio, LLP

Agent Attorney Phone

617-742-4444

Agent Attorney Address 1

18 Tremont Street

Agent Attorney Address 2

Suite 601

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2108

Agent Attorney Email

laurie@costariccio.com

PW Track Number

P10020241793185

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

100880.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-02-03

PW Expiration Date

2021-06-30

Wage Offer From

128700.00

Wage Offer To

0.00

Average Salary

128700.00

Wage Unit of Pay

Year

Worksite Address 1

117 Kendrick Street

Worksite Address 2

Suite 500

Worksite City

Needham

Worksite City Slug

needham

Worksite State

MASSACHUSETTS

Worksite Postal Code

2494

Job Title

Senior Manager, Regulatory Affairs

Job Title Slug

senior-manager-regulatory-affairs

Minimum Education

Master's

Major Field of Study

Regulatory Affairs, or related scientific discipline.

Required Training

N

Required Experience

Y

Required Experience Months

48

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Closely related scientific discipline to Regulatory Affairs.

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

48

Accept Alternative Job Title

Work experience in the job offered cont. in H.14.

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

H. 10B. cont. or related of Regulatory Affairs in the biopharmaceutical industry with global regulatory experience. Pre or post degree experience is acceptable.br br Special Skillsbr br Must have at least 4 years of experience filing global submissions to regulatory authorities INDs, BLAs, NDAs, and sNDAs.br Must have at least 4 years of experience simultaneously handling multiple project issues while dealing with time demands, incomplete information, or unexpected events.br Must have at least 4 years of experience with drug and biologic development process.br Must have at least 4 years of experience with clinical research process including medical and clinical terminology.br Must have at least 4 years of experience with nonclinical research process including terminology.br Must have at least 4 years of experience with manufacturing processes including terminology.br Must have at least 4 years of experience working with U.S. Federal Regulations related to clinical research 21 CFR Parts 50, 56, 312, ICH guidelines, and with GLP and GMP requirements and guidelines 21 CFR 58, 210 and 211.

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

2021-02-18

SWA Job Order End Date

2021-03-22

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2021-02-28

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-03-07

Employer Website From Date

2021-02-18

Employer Website To Date

2021-03-22

Professional Organization Ad From Date

2022-01-01 10:34:29

Professional Organization Advertisement To Date

2022-01-01 10:34:29

Job Search Website From Date

2021-03-02

Job Search Website To Date

2021-03-16

Employee Referral Program From Date

2021-02-17

Employee Referral Program To Date

2021-03-02

Local Ethnic Paper From Date

2022-01-01 10:34:29

Local Ethnic Paper To Date

2022-01-01 10:34:29

Radio/TV Ad From Date

2022-01-01 10:34:29

Radio/TV Ad To Date

2022-01-01 10:34:29

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

2015

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVE.

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

Laurie B Riccio

Preparer Title

Partner

Preparer Email

laurie@costariccio.com

Employer Information Declaration Name

Catherine Peper

Employer Information Declaration Title

Chief Organizational Effectiveness Officer