Fiscal Year

2020

Case Number

A-19149-11056

Case Status

Certified-Expired

Received Date

2019-07-18

Decision Date

2019-10-09

Refile

N

Original File Date

2020-01-01 07:21:11

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

6175740400

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

P10018227008767

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level II

PW Wage

72446.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-01-16

PW Expiration Date

2019-06-30

Wage Offer From

79100.00

Wage Offer To

131900.00

Average Salary

105500.00

Wage Unit of Pay

Year

Worksite Address 1

225 Binney Street

Worksite Address 2

Worksite City

Cambridge

Worksite City Slug

cambridge

Worksite State

MASSACHUSETTS

Worksite Postal Code

2142

Job Title

Senior Associate II, Drug Safety Quality (SABR)

Job Title Slug

senior-associate-ii-drug-safety-quality-sabr

Minimum Education

Master's

Major Field of Study

Life Science

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Regulatory Affairs, or a directly related field

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

24

Accept Alternative Job Title

Experience in the Biotechnology or Pharmaceutical industry.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Experience must includebr br Two 2 years of experience with the followingbr Post Marketing and Clinical Trial pharmacovigilance regulationsbr Global Safety Database User experience with processing of clinical trial, post marketing and literature cases, using ARISg or ARGUSbr Excelbr br One 1 year of experience with the followingbr Direct experience in GXP compliant quality systemsbr Developing compliance metricsbr Developing and supporting process improvementsbr br Six 6 months of experience with the followingbr Writing andor reviewing CAPA andor late case investigationsbr Supporting logistics and preparation for PV inspections and regulatory authority auditsbr br Will accept a Bachelors degree plus five 5 years of described experience. Experience may be gained before, during, or after advanced degree.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

2019-03-13

SWA Job Order End Date

2019-04-15

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Globe

First Advertisement Start Date

2019-03-17

Second Newspaper Ad Name

Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-03-24

Employer Website From Date

2019-02-27

Employer Website To Date

2019-03-22

Professional Organization Ad From Date

2020-01-01 07:21:11

Professional Organization Advertisement To Date

2020-01-01 07:21:11

Job Search Website From Date

2019-03-20

Job Search Website To Date

2019-04-02

Employee Referral Program From Date

2020-01-01 07:21:11

Employee Referral Program To Date

2020-01-01 07:21:11

Local Ethnic Paper From Date

2019-03-20

Local Ethnic Paper To Date

2019-03-20

Radio/TV Ad From Date

2020-01-01 07:21:11

Radio/TV Ad To Date

2020-01-01 07:21:11

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 AVE

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

Erin M Brummer

Preparer Title

Attorney

Preparer Email

atty.lesterteam@fragomen.com

Employer Information Declaration Name

Dunne Alissa

Employer Information Declaration Title

HR, Immigration Specialist