Fiscal Year

2024

Case Number

A-23104-27583

Case Status

Certified

Received Date

2023-04-17

Decision Date

2024-05-08

Refile

N

Original File Date

2024-01-01 01:18:48

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

TAKEDA DEVELOPMENT CENTER AMERICAS, INC.

Employer Name Slug

takeda-development-center-americas-inc

Employer Address 1

95 HAYDEN AVE

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

224-544-1749

Employer Number of Employees

19608

Employer Year Commenced Business

2003

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Ken Brown

Employer Contact Address 1

95 Hayden Ave

Employer Contact Address 2

Employer Contact City

Lexington

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2421

Employer Contact Phone

617-794-2549

Employer Contact Email

ken.brown@takeda.com

Agent Attorney Name

Karen C Selking

Agent Attorney Firm Name

Zulkie Partners LLC

Agent Attorney Phone

(312) 831-2124

Agent Attorney Address 1

135 South La Salle 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

kselking@zulkiepartners.com

PW Track Number

P10022117113705

PW SOC Code

11-9199.00

PW SOC Title

Managers, All Other

PW Skill Level

Level II

PW Wage

120078.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-11-14

PW Expiration Date

2023-06-30

Wage Offer From

130200.00

Wage Offer To

251100.00

Average Salary

190650.00

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

Sr. Manager PV Clinical Safety Operations Oversight

Job Title Slug

sr-manager-pv-clinical-safety-operations-oversight

Minimum Education

Bachelor's

Major Field of Study

Scientific or medical field or related field or foreign equivalent degree

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

Sr. Mgr, Clinical Trial PV Operations Oversight, Manager, Clinical Trial PV Operations Oversight, Cl

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Ensure patient safety during the conduct of clinical trials by timely assessment and reporting of adverse events. Ensure timely reporting of adverse events in accordance with global regulatory requirements including but not limited to FDA, EMA, PMDA. Setup systems and processes to ensure compliance with FDA CFRCode of Federal Regulations Title 21 CFR 812 IDE Regulations governing patient safety during clinical trials. Setup systems and processes to ensure compliance with FDA CFRCode of Federal Regulations Title 21 CFR 312.32 IND Safety Reporting and global regulations governing patient safety during clinical trials. Develop procedural documents to govern pharmacovigilance in the context of clinical trials. Review metrics and Key Performance Indicators to oversee tasks performed by external vendors. H10B Sr. Mgr, Clinical Trial PV Operations Oversight, Manager, Clinical Trial PV Operations Oversight, Clinical Safety Operations Lead, Regulatory Associate, Reg Documentation Specialist, Adverse Event Reporting Associate, Clinical Submission Specialist or related position

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

2022-12-16

SWA Job Order End Date

2023-01-17

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Sunday Globe

First Advertisement Start Date

2023-02-12

Second Newspaper Ad Name

Boston Sunday Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2023-02-19

Employer Website From Date

2022-12-16

Employer Website To Date

2023-03-22

Professional Organization Ad From Date

2024-01-01 01:18:48

Professional Organization Advertisement To Date

2024-01-01 01:18:48

Job Search Website From Date

2023-02-12

Job Search Website To Date

2023-03-13

Employee Referral Program From Date

2024-01-01 01:18:48

Employee Referral Program To Date

2024-01-01 01:18:48

Local Ethnic Paper From Date

2023-02-16

Local Ethnic Paper To Date

2023-02-16

Radio/TV Ad From Date

2024-01-01 01:18:48

Radio/TV Ad To Date

2024-01-01 01:18:48

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

2016

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

02115-5000

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Karen C Selking

Preparer Title

Principal

Preparer Email

kselking@zulkiepartners.com

Employer Information Declaration Name

Ken Brown

Employer Information Declaration Title

Global Mobility Strategy Lead