Fiscal Year

2024

Case Number

A-23117-34093

Case Status

Certified

Received Date

2023-05-01

Decision Date

2024-06-03

Refile

N

Original File Date

2024-01-01 01:33:46

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

IRONWOOD PHARMACEUTICALS INC.

Employer Name Slug

ironwood-pharmaceuticals-inc

Employer Address 1

301 BINNEY STREET

Employer Address 2

2ND FLOOR

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

617-621-7722

Employer Number of Employees

320

Employer Year Commenced Business

1998

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Phyllis Sokolov

Employer Contact Address 1

100 Summer Street

Employer Contact Address 2

Suite 2300

Employer Contact City

Boston

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2110

Employer Contact Phone

617-374-4829

Employer Contact Email

psokolov@ironwoodpharma.com

Agent Attorney Name

Laurie B Riccio

Agent Attorney Firm Name

Costa Riccio, LLP

Agent Attorney Phone

(617) 742-4444

Agent Attorney Address 1

18 Tremont Street

Agent Attorney Address 2

Suite 601

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2108

Agent Attorney Email

laurie@costariccio.com

PW Track Number

P10022188337679

PW SOC Code

15-1299.03

PW SOC Title

Document Management Specialists

PW Skill Level

Level IV

PW Wage

121555.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2023-01-13

PW Expiration Date

2023-06-30

Wage Offer From

141807.02

Wage Offer To

0.00

Average Salary

141807.02

Wage Unit of Pay

Year

Worksite Address 1

100 Summer Street

Worksite Address 2

Suite 2300

Worksite City

Boston

Worksite City Slug

boston

Worksite State

MASSACHUSETTS

Worksite Postal Code

2110

Job Title

Manager, Quality Systems and Compliance

Job Title Slug

manager-quality-systems-and-compliance

Minimum Education

Bachelor's

Major Field of Study

Pharmaceutical Sciences, Regulatory Affairs, or related scientific/technical field

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

related scientifictechnical field to Pharmaceutical Sciences or Regulatory Affairs

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

3

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

Work experience in the job offered or related field of pharmaceutical compliance oversight cont. in

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

H. 10B. cont.; or in the alternative, a Masters degree or equivalent and three years of work experience. Specific skills If qualifying with a Bachelors degree, must have the following Five years of experience working in a cGMPGXP environment; Three years of experience as a Quality System Software administrator; Five years of experience with applicable regulations and guidance, such as Food and Drug Administration FDA guidelines 21 CFR parts 11, 210, 211, 800, 820; Data Integrity and Compliance with Drug CGMP Guidance for Industry; FDA General Principles of Software Validation; FDA Guidance Document Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations; ICH Q8, Q9, and Q10; and Three years of experience with practical application of riskbased approach to quality system principles and regulatory compliance within the pharmaceutical industry. If qualifying with a Master s degree, must have the following Three years of experience working in a cGMPGXP environment; One year of experience as a Quality System Software administrator; Three years of experience with applicable regulations and guidance, such as Food and Drug Administration FDA guidelines 21 CFR parts 11, 210, 211, 800, 820; Data Integrity and Compliance with Drug CGMP Guidance for Industry; FDA General Principles of Software Validation; FDA Guidance Document Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations; ICH Q8, Q9, and Q10; and Two years of experience with practical application of riskbased approach to quality system principles and regulatory compliance within the pharmaceutical industry. Ironwood has adopted a hybrid work environment where employees have the option to work from home within normal commuting distance from the office location. Vaccination and testing required for inoffice work.

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

2023-01-25

SWA Job Order End Date

2023-02-27

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Globe

First Advertisement Start Date

2023-02-05

Second Newspaper Ad Name

Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2023-02-12

Employer Website From Date

2023-01-24

Employer Website To Date

2023-02-27

Professional Organization Ad From Date

2024-01-01 01:33:46

Professional Organization Advertisement To Date

2024-01-01 01:33:46

Job Search Website From Date

2023-02-02

Job Search Website To Date

2023-02-16

Employee Referral Program From Date

2023-01-25

Employee Referral Program To Date

2023-02-08

Local Ethnic Paper From Date

2024-01-01 01:33:46

Local Ethnic Paper To Date

2024-01-01 01:33:46

Radio/TV Ad From Date

2024-01-01 01:33:46

Radio/TV Ad To Date

2024-01-01 01:33:46

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

2015

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

Laurie B Riccio

Preparer Title

Partner

Preparer Email

laurie@costariccio.com

Employer Information Declaration Name

Jason Rickard

Employer Information Declaration Title

Senior Vice President, Chief Operating Officer