Fiscal Year

2021

Case Number

A-20208-80979

Case Status

Certified

Received Date

2020-08-13

Decision Date

2021-07-07

Refile

N

Original File Date

2021-01-01 09:46:28

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

BLUEBIRD BIO, INC.

Employer Name Slug

bluebird-bio-inc

Employer Address 1

60 BINNEY 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

2142

Employer Phone

6178037712

Employer Number of Employees

927

Employer Year Commenced Business

1992

NAICS Code

541710

FW Ownership Interest

N

Employer Contact Name

Margaret A King

Employer Contact Address 1

60 Binney 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

617-335-9939

Employer Contact Email

mking@bluebirdbio.com

Agent Attorney Name

Rhonda A Tietjen

Agent Attorney Firm Name

Ross Silverman Snyder Tietjen LLP

Agent Attorney Phone

617-542-5111

Agent Attorney Address 1

50 Congress Street

Agent Attorney Address 2

Suite 200

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2109

Agent Attorney Email

rt@rsstlawgroup.com

PW Track Number

P10020044321254

PW SOC Code

15-1121

PW SOC Title

Computer Systems Analysts

PW Skill Level

Level IV

PW Wage

110469.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-05-05

PW Expiration Date

2020-08-03

Wage Offer From

120000.00

Wage Offer To

0.00

Average Salary

120000.00

Wage Unit of Pay

Year

Worksite Address 1

60 Binney Streeet

Worksite Address 2

Worksite City

Cambridge

Worksite City Slug

cambridge

Worksite State

MASSACHUSETTS

Worksite Postal Code

2142

Job Title

eTMF Operations Manager

Job Title Slug

etmf-operations-manager

Minimum Education

Master's

Major Field of Study

Regulatory Affairs, Biomedical Sciences, or related field

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

7

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

Any occupation in which applicant can gain experience listed in H.14

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

H.10B Must have 5 years of biopharmabiotech industry experience supporting the operations of clinical studies, including duties related to records management and maintenance of TMFeTMF; working with ICHGCP, FDA, and EMA regulations; and working with DIA TMF reference model. We will also accept a BS and 7 years of stated experience.br H12 PLEASE NOTE that the requirements bear a reasonable relationship to the occupation of Computer Systems Analysts in the context of the pharmaceutical industry and are essential to perform the job in a reasonable manner. This is a senior position within the Clinical Operations Department and we would not hire anyone who did not possess these credentials. This employee must have the indepth, complex, and theoretical understanding of regulatory affairs compliance in the biomedical research industry, gained through a university degree, in order to provide the level of knowledge to solve the unique and complex technical problems required of this position. As this employee is accountable for bluebird bios eTMF system, creates all studies in the Veeva Vault eTMF, and reviews and approves eTMF user access for CDO, his technical skills must be excellent. In addition, because of the senior nature of this position, the advanced responsibilities it entails including serving as the companys eTMF system expert, ensuring study workflows and document lifecycle follow bluebirds SOPs. the industryspecific duties including conducting Quality Control QC review of clinical, regulatory, safety, IRB, supply chain, labs, statistics vendor study documentation in the eTMF, and the serious consequences of data error when working within the highly regulated pharmaceutical industry, the employer requires extensive handson experience. We have determined that a Masters and 7 years of experience or a Bachelors and 7 years of progressively responsible postdegree experience are the minimum qualifications necessary to perform this position. Please note that we have developed alternate requirements to increase our applicant pool.

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

2020-05-23

SWA Job Order End Date

2020-06-23

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2020-05-24

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-05-31

Employer Website From Date

2021-01-01 09:46:28

Employer Website To Date

2021-01-01 09:46:28

Professional Organization Ad From Date

2020-05-23

Professional Organization Advertisement To Date

2020-06-22

Job Search Website From Date

2020-05-23

Job Search Website To Date

2020-07-23

Employee Referral Program From Date

2021-01-01 09:46:28

Employee Referral Program To Date

2021-01-01 09:46:28

Local Ethnic Paper From Date

2021-01-01 09:46:28

Local Ethnic Paper To Date

2021-01-01 09:46:28

Radio/TV Ad From Date

2021-01-01 09:46:28

Radio/TV Ad To Date

2021-01-01 09:46:28

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

2115

Foreign Worker Experience with Employer

N/A

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Rhonda A Tietjen

Preparer Title

Attorney

Preparer Email

rt@rsstlawgroup.com

Employer Information Declaration Name

Margaret King

Employer Information Declaration Title

People Operations Specialist