Fiscal Year

2022

Case Number

A-21270-50427

Case Status

Certified

Received Date

2021-10-01

Decision Date

2022-04-21

Refile

N

Original File Date

2022-01-01 11:18:04

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

SHIRE HUMAN GENETIC THERAPIES SHGT INC

Employer Name Slug

shire-human-genetic-therapies-shgt-inc

Employer Address 1

300 SHIRE WAY

Employer Address 2

Employer City

LEXINGTON

Employer City Slug

lexington

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2421

Employer Phone

781-482-0599

Employer Number of Employees

47495

Employer Year Commenced Business

1994

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Patty Chookhae-Kragh

Employer Contact Address 1

650 East Kendall Street

Employer Contact Address 2

Employer Contact City

Cambridge

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2142

Employer Contact Phone

617-588-8463

Employer Contact Email

patty.chookhae-kragh@shire.com

Agent Attorney Name

Jennifer A Hoskin

Agent Attorney Firm Name

Zulkie Partners LLC

Agent Attorney Phone

(312) 831-2132

Agent Attorney Address 1

135 S LaSalle Street

Agent Attorney Address 2

Ste. 3425

Agent Attorney City

Chicago

Agent Attorney State/Province

ILLINOIS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60603

Agent Attorney Email

jhoskin@zulkiepartners.com

PW Track Number

P10021034051206

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level III

PW Wage

85966.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-06-17

PW Expiration Date

2021-09-15

Wage Offer From

101500.00

Wage Offer To

195800.00

Average Salary

148650.00

Wage Unit of Pay

Year

Worksite Address 1

650 E. Kendall Street

Worksite Address 2

Worksite City

Cambridge

Worksite City Slug

cambridge

Worksite State

MASSACHUSETTS

Worksite Postal Code

2142

Job Title

US & International Regulatory Strategist

Job Title Slug

us-international-regulatory-strategist

Minimum Education

Master's

Major Field of Study

PHARMACY OR RELATED FIELD

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

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

12

Accept Alternative Job Title

Doc Control Coordinator or rltd pstn

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

REQUIRED SKILLS PERFORM DOCUMENT CONTROL ACTIVITIES INCLUDING ISSUANCE, DISTRIBUTION, TRACKING, MONITORING, REVIEW AND ARCHIVAL OF SOPS, WORK INSTRUCTIONS, QUALITY MANUALS, TECHNICAL FILES, MASTER SPECIFICATIONS, TEST METHODS, STUDY PROTOCOLS AND REPORTS; ENSURE THAT DOCUMENT MANAGEMENT STRATEGIES AND REGULATORY REQUIREMENTS ARE UPHELD WITH RESPECT TO INTERNAL AND EXTERNAL QUALITY AND REGULATORY STANDARDS; IMPLEMENT GDP GUIDELINES FOR ALL CRITICAL DOCUMENTS SUCH AS ANALYTICAL TEST METHODS, CERTIFICATE OF ANALYSIS, PROTOCOLS, CHANGE CONTROL ASSESSMENTS, PRODUCT AND SAMPLE LABELS TO ENSURE COMPLIANCE WITH REGULATIONS US FDA GLP 21 CFR PART 58, CGMP 21 CFR PART 211 AND WHO ANNEX 5. 1020 TRAVEL REQUIRED.

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

2021-07-23

SWA Job Order End Date

2021-08-24

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2021-07-18

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-07-25

Employer Website From Date

2021-07-16

Employer Website To Date

2021-08-25

Professional Organization Ad From Date

2022-01-01 11:18:04

Professional Organization Advertisement To Date

2022-01-01 11:18:04

Job Search Website From Date

2021-07-18

Job Search Website To Date

2021-08-16

Employee Referral Program From Date

2022-01-01 11:18:04

Employee Referral Program To Date

2022-01-01 11:18:04

Local Ethnic Paper From Date

2021-07-22

Local Ethnic Paper To Date

2021-07-22

Radio/TV Ad From Date

2022-01-01 11:18:04

Radio/TV Ad To Date

2022-01-01 11:18:04

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

PHARMACY QUALITY ASSURANCE TECHNIQUES

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

UNIVERSITY OF PUNE

Foreign Worker Education Institution Address 1

GANESHKHIND RD, GANESHKHIND

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

PUNE

Foreign Worker Education Institution State/Province

MAHARASHTRA

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

411007

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Jennifer A Hoskin

Preparer Title

Associate

Preparer Email

jhoskin@zulkiepartners.com

Employer Information Declaration Name

Paul Lambert

Employer Information Declaration Title

Global Mobility Manager