Fiscal Year

2022

Case Number

A-21242-37896

Case Status

Certified

Received Date

2021-10-06

Decision Date

2022-04-22

Refile

N

Original File Date

2022-01-01 11:18:37

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

MDC Associates, Inc.

Employer Name Slug

mdc-associates-inc

Employer Address 1

180 CABOT ST STE 2

Employer Address 2

Employer City

BEVERLY

Employer City Slug

beverly

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

1915

Employer Phone

978-705-5019

Employer Number of Employees

16

Employer Year Commenced Business

2019

NAICS Code

541690

FW Ownership Interest

N

Employer Contact Name

Lisa Kelly

Employer Contact Address 1

180 CABOT ST STE 2

Employer Contact Address 2

Employer Contact City

BEVERLY

Employer Contact State/Province

MASSACHUSETTS Joen Amex

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

1915

Employer Contact Phone

9784732887

Employer Contact Email

lisa@mdcassoc.com

Agent Attorney Name

Charles J Gloski

Agent Attorney Firm Name

Wolfsdorf Rosenthal, LLP WR Immigration

Agent Attorney Phone

6177485179

Agent Attorney Address 1

100 High Street, Suite 1300

Agent Attorney Address 2

Agent Attorney City

Boston

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2110

Agent Attorney Email

jgloski@wolfsdorf.com

PW Track Number

P10020335931143

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialist

PW Skill Level

Level IV

PW Wage

100880.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-04-12

PW Expiration Date

2021-07-11

Wage Offer From

120000.00

Wage Offer To

135000.00

Average Salary

127500.00

Wage Unit of Pay

Year

Worksite Address 1

180 Cabot Street

Worksite Address 2

Worksite City

Beverly

Worksite City Slug

beverly

Worksite State

MASSACHUSETTS

Worksite Postal Code

1915

Job Title

Regulatory and Clinical Affairs Specialist

Job Title Slug

regulatory-and-clinical-affairs-specialist

Minimum Education

Bachelor's

Major Field of Study

Health care or other related scientific discipline

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Please see H.14

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

Please see H.14

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

H.410 Requirements Bachelors degree in health care or other related scientific discipline, plus 5 years of experience in clinical trial management andor regulatory affairs activities. H.14 Skills Must have demonstrated indepth knowledge of, and skill in applying, applicable clinical research regulatory requirements such as Good Clinical Practice GCP and International Conference on Harmonisation ICH; demonstrated understanding of FDA laws and guidance; demonstrated understanding of EU IVDR; demonstrated understanding of IRB guidelines and Common Rule; demonstrated proficiency in use of Microsoft Word, Excel, Outlook, and PowerPoint; demonstrated strong written and verbal communication skills; demonstrated excellent organizational and problemsolving skills; demonstrated effective time management skills; demonstrated attention to detail and accuracy in work; demonstrated ability to manage competing priorities without compromising quality; demonstrated effective mentoring and training skills; and demonstrated ability to establish and maintain effective collaborative relationships with coworkers, managers, and clients. Unless otherwise indicated, employer is seeking ability in the skills above with no specific amount of years of experience required. All experience can be gained concurrently. 25 domestic and international travel required. Telecommuting allowed.

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

2021-07-08

SWA Job Order End Date

2021-08-10

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Globe

First Advertisement Start Date

2021-07-04

Second Newspaper Ad Name

Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-07-11

Employer Website From Date

2021-06-22

Employer Website To Date

2021-07-27

Professional Organization Ad From Date

2022-01-01 11:18:37

Professional Organization Advertisement To Date

2022-01-01 11:18:37

Job Search Website From Date

2021-06-28

Job Search Website To Date

2021-07-13

Employee Referral Program From Date

2021-06-22

Employee Referral Program To Date

2021-07-27

Local Ethnic Paper From Date

2022-01-01 11:18:37

Local Ethnic Paper To Date

2022-01-01 11:18:37

Radio/TV Ad From Date

2022-01-01 11:18:37

Radio/TV Ad To Date

2022-01-01 11:18:37

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

Doctorate

Foreign Worker Information: Major

PHARMACOLOGY

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

ST. JOHNS UNIVERSITY

Foreign Worker Education Institution Address 1

8000 UTOPIA PARKWAY

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

QUEENS

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

11439

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Charles J Gloski

Preparer Title

Senior Attorney

Preparer Email

jgloski@wolfsdorf.com

Employer Information Declaration Name

Lisa Kelly

Employer Information Declaration Title

Accounting and Human Resources Manager