Fiscal Year

2022

Case Number

A-21293-60824

Case Status

Certified

Received Date

2021-10-21

Decision Date

2022-05-20

Refile

N

Original File Date

2022-01-01 11:30:45

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

P10021013010376

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level II

PW Wage

106413.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-06-30

PW Expiration Date

2021-09-28

Wage Offer From

107000.00

Wage Offer To

195800.00

Average Salary

151400.00

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

Mgr, US/Intl Reg Strategist, Global Reg Affairs Strategy

Job Title Slug

mgr-usintl-reg-strategist-global-reg-affairs-strategy

Minimum Education

Bachelor'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

36

Accept Alternative Job Title

Reg Affairs Coordinator or rltd pstn

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

WILL ACCEPT ANY LEVEL OF EXPERIENCE IN THE FOLLOWING SKILLS DESIGN, ESTABLISH AND IMPLEMENT QSR SYSTEM QUALITY SYSTEM REGULATION INCLUDING CREATION OF SOP, DEVELOP WORKFLOW FOR APPROVAL PROCESSES AND REGULATORY DOCUMENTATION FOR MEDICAL DEVICE; ANALYZE REGULATORY GUIDANCES FDA TITLE 21 CFR PART 820,801, 812,807,814, DETERMINE CLASSIFICATION PART 860, GCP AND ICH, ISO 13485 GUIDELINES RELATED TO MEDICAL DEVICE DEVELOPMENT; EXTRACT PHARMACEUTICAL PRODUCTSCOMPETITORSPRESCRIPTION TRENDS DATA FROM ORG IMS DATABASE PHARMACEUTICAL MARKET DATABASE, EVALUATE HEALTHCARE INFORMATION USING TOOLS, DEVELOP AND IMPLEMENT STRATEGY AND BUSINESS DEVELOPMENT PLAN FOR PHARMACEUTICALS; ENGAGE INTERNAL AND EXTERNAL STAKEHOLDERS, MANAGE, REVIEW AND EVALUATE PROMOTIONAL MATERIALS FOR PHARMACEUTICALS PRODUCTS IN COMPLIANCE WITH GUIDELINES FROM THE CENTRAL DRUGS STANDARD CONTROL ORGANIZATION CDSCO, THE DRUGS AND COSMETICS ACT DCA, 1940 AND THE DRUGS AND COSMETICS RULES 1945. 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

2021-07-25

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-08-01

Employer Website From Date

2021-07-23

Employer Website To Date

2021-08-25

Professional Organization Ad From Date

2022-01-01 11:30:45

Professional Organization Advertisement To Date

2022-01-01 11:30:45

Job Search Website From Date

2021-07-25

Job Search Website To Date

2021-08-23

Employee Referral Program From Date

2022-01-01 11:30:45

Employee Referral Program To Date

2022-01-01 11:30:45

Local Ethnic Paper From Date

2021-07-29

Local Ethnic Paper To Date

2021-07-29

Radio/TV Ad From Date

2022-01-01 11:30:45

Radio/TV Ad To Date

2022-01-01 11:30:45

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

PHARMACY

Foreign Worker Years of Education Completed

2005

Foreign Worker Institution of Education

HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY PATAN

Foreign Worker Education Institution Address 1

MOTIPURA, HIMATNAGAR, NH8

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

HIMMATNAGAR

Foreign Worker Education Institution State/Province

GUJARAT

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

383001

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