Fiscal Year

2020

Case Number

A-19213-38591

Case Status

Certified-Expired

Received Date

2019-09-03

Decision Date

2019-11-25

Refile

N

Original File Date

2020-01-01 07:46:01

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

BIOGEN, INC.

Employer Name Slug

biogen-inc

Employer Address 1

225 BINNEY STREET

Employer Address 2

BUILDING 1

Employer City

CAMBRIDGE

Employer City Slug

cambridge

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2142

Employer Phone

617-679-6299

Employer Number of Employees

7400

Employer Year Commenced Business

2003

NAICS Code

325414

FW Ownership Interest

N

Employer Contact Name

Alissa Dunne

Employer Contact Address 1

225 Binney Street

Employer Contact Address 2

Building 1

Employer Contact City

Cambridge

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2142

Employer Contact Phone

617-914-6009

Employer Contact Email

alissa.dunne@biogen.com

Agent Attorney Name

Erin M Brummer

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy, LLP

Agent Attorney Phone

617-574-0400

Agent Attorney Address 1

100 High Street

Agent Attorney Address 2

3rd Floor

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2110

Agent Attorney Email

atty.lesterteam@fragomen.com

PW Track Number

P10018299653054

PW SOC Code

11-3051

PW SOC Title

Quality Control Systems Managers

PW Skill Level

Level III

PW Wage

130936.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-03-01

PW Expiration Date

2019-06-30

Wage Offer From

130940.00

Wage Offer To

152500.00

Average Salary

141720.00

Wage Unit of Pay

Year

Worksite Address 1

225 Binney Street

Worksite Address 2

Building 1

Worksite City

Cambridge

Worksite City Slug

cambridge

Worksite State

MASSACHUSETTS

Worksite Postal Code

2142

Job Title

Global Medical Information Quality Assurance Manager

Job Title Slug

global-medical-information-quality-assurance-manager

Minimum Education

Master's

Major Field of Study

Life Sciences

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Biology, Biochemistry or a directly related field

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

24

Accept Alternative Job Title

Direct quality monitoring experience within a Medical or PV function in a quality assurance role

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Experience must includebr br Two 2 years of experience with each of the following experience may be gained concurrentlybr br Proficiency in regulatory compliance standards, particularly GVP Good Pharmacovigilance Practicebr Working with and adhering to regulatory policies governing scientific interactions with health care providers and patientsbr Technical writing experience involving standard operating procedures, job aids, CAPAs and similar documentsbr Vendor management experience serving in a liaison role with the ability to make decisions and perform necessary tasks as needed to ensure efficiency and transparencybr Quality Assurance and GxP Good x Practice, including pharmacovigilance GPvP, Good Distribution Practice GDP, or Good Clinical Practice GCPbr Identifying necessary corrective actions and ensuring compliance with regional and local regulations.br Establishing and monitoring enquiry trends and metrics.br Identifying gaps in compliance standards with detailed corrective plans, as required.br Monitoring the appropriate capture of any related adverse event or product complaint information.br br Any suitable combination of education, training, or experience is acceptable.

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

2019-05-22

SWA Job Order End Date

2019-06-26

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Sunday Globe

First Advertisement Start Date

2019-06-09

Second Newspaper Ad Name

The Boston Sunday Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-06-16

Employer Website From Date

2020-01-01 07:46:01

Employer Website To Date

2020-01-01 07:46:01

Professional Organization Ad From Date

2020-01-01 07:46:01

Professional Organization Advertisement To Date

2020-01-01 07:46:01

Job Search Website From Date

2019-06-12

Job Search Website To Date

2019-06-25

Employee Referral Program From Date

2019-05-20

Employee Referral Program To Date

2019-06-03

Local Ethnic Paper From Date

2019-06-13

Local Ethnic Paper To Date

2019-06-13

Radio/TV Ad From Date

2020-01-01 07:46:01

Radio/TV Ad To Date

2020-01-01 07:46:01

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

BIOLOGY

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

LOUISIANA TECH UNIVERSITY

Foreign Worker Education Institution Address 1

LOUISIANA TECH UNIVERSITY

Foreign Worker Education Institution Address 2

305 WISTERIA STREET

Foreign Worker Education Institution City

RUSTON

Foreign Worker Education Institution State/Province

LA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

71272

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Erin M Brummer

Preparer Title

Attorney

Preparer Email

atty.lesterteam@fragomen.com

Employer Information Declaration Name

Alissa Dunne

Employer Information Declaration Title

HR, Immigration Specialist