Fiscal Year

2022

Case Number

A-21301-64697

Case Status

Certified

Received Date

2021-10-30

Decision Date

2022-05-06

Refile

N

Original File Date

2022-01-01 11:24:52

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

MILLENNIUM PHARMACEUTICALS, INC.

Employer Name Slug

millennium-pharmaceuticals-inc

Employer Address 1

40 LANDSDOWNE STREET

Employer Address 2

Employer City

CAMBRIDGE

Employer City Slug

cambridge

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2139

Employer Phone

(617) 679-7000

Employer Number of Employees

18000

Employer Year Commenced Business

1993

NAICS Code

325411

FW Ownership Interest

N

Employer Contact Name

Paul Lambert

Employer Contact Address 1

45 Hayden Avenue

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

617.588.8655

Employer Contact Email

paul.lambert@takeda.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

kselking@zulkiepartners.com

PW Track Number

P10021057105332

PW SOC Code

11-9199

PW SOC Title

Regulatory Affairs Managers

PW Skill Level

Level IV

PW Wage

168210.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-07-21

PW Expiration Date

2022-06-30

Wage Offer From

169000.00

Wage Offer To

240300.00

Average Salary

204650.00

Wage Unit of Pay

Year

Worksite Address 1

200 Shire Way

Worksite Address 2

Worksite City

Lexington

Worksite City Slug

lexington

Worksite State

MASSACHUSETTS

Worksite Postal Code

2421

Job Title

Strategist, Device Regulatory Affairs, PDT BU

Job Title Slug

strategist-device-regulatory-affairs-pdt-bu

Minimum Education

Master's

Major Field of Study

Regulatory Affairs 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

60

Accept Alternative Job Title

Mgr Regulatory Affairs or rltd pstn

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Required skills experience in IDE, PMA, Presubmission, 510k, Letter file processes and knowledge of FDA 21 CFR 820 quality system regulations 5 yrs; lead and execute regulatory activities for companion diagnostics CDx projects by collaborating with various pharmaceutical partners and create regulatory strategy for medical device submissions including Class I, II, III medical devices and companion diagnostics 2 yrs, 6 mos; knowledge of labelling registration needs and changing regulations for EU member states, China, Japan, Singapore, Malaysia, Colombia, Sri Lanka, Turkey, Saudi Arabia, Canada, India 2 yrs; conduct change control assessments and experience in Corrective and Preventive Action CAPA, Internal audits, quality training, labeling review 4 yrs; experience and working knowledge on current regulations and guidance on devices, vitro diagnostics, combination products including EU Medical Device Regulation, European Union In Vitro Device Regulation, European Norm, International Organization for Standardization including ISO 18113, EN ISO 15223, ISO 23640, ISO20916, Clinical Laboratory Improvement Amendments CLIA and ISO 15189 requirements, ISO 11608, ISO 13485, ISO 14971, ISO 10993, ISO 7864, ISO 9626, Compendia 5 yrs; identify and assess regulatory and compliance risks associated with product development and life cycle management activities. Support risk benefit analysis failure mode and effects analysis FMEA 2 yrs. 1520 national and international 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

2021-08-26

SWA Job Order End Date

2021-09-27

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2021-08-29

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-09-05

Employer Website From Date

2021-08-26

Employer Website To Date

2021-09-27

Professional Organization Ad From Date

2022-01-01 11:24:52

Professional Organization Advertisement To Date

2022-01-01 11:24:52

Job Search Website From Date

2021-08-29

Job Search Website To Date

2021-09-27

Employee Referral Program From Date

2022-01-01 11:24:52

Employee Referral Program To Date

2022-01-01 11:24:52

Local Ethnic Paper From Date

2021-08-26

Local Ethnic Paper To Date

2021-08-26

Radio/TV Ad From Date

2022-01-01 11:24:52

Radio/TV Ad To Date

2022-01-01 11:24:52

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

2014

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

Jennifer A Hoskin

Preparer Title

Associate

Preparer Email

jhoskin@zulkiepartners.com

Employer Information Declaration Name

Paul Lambert

Employer Information Declaration Title

Global Mobility Manager