Fiscal Year

2023

Case Number

A-22110-43255

Case Status

Certified

Received Date

2022-04-22

Decision Date

2022-12-28

Refile

N

Original File Date

2023-01-01 17:57:42

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Epizyme, Inc.

Employer Name Slug

epizyme-inc

Employer Address 1

400 Technology Square

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

2139

Employer Phone

(617) 229-5872

Employer Number of Employees

112

Employer Year Commenced Business

2007

NAICS Code

541710

FW Ownership Interest

N

Employer Contact Name

Casey Hall

Employer Contact Address 1

400 Technology Square

Employer Contact Address 2

Employer Contact City

Cambridge

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2139

Employer Contact Phone

(617) 300-0285

Employer Contact Email

chall@epizyme.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

P10021172414969

PW SOC Code

15-2041

PW SOC Title

Clinical Data Managers

PW Skill Level

Level IV

PW Wage

140192.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-11-26

PW Expiration Date

2022-06-30

Wage Offer From

140192.00

Wage Offer To

0.00

Average Salary

140192.00

Wage Unit of Pay

Year

Worksite Address 1

400 Technology Square

Worksite Address 2

Worksite City

Cambridge

Worksite City Slug

cambridge

Worksite State

MASSACHUSETTS

Worksite Postal Code

2139

Job Title

Senior Clinical Data Manager

Job Title Slug

senior-clinical-data-manager

Minimum Education

Bachelor's

Major Field of Study

Regulatory Affairs, Pharmacy, 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

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

Any occupation in which the applicant gains the experience listed in H.14

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

WILL CONSIDER ANY APPLICANT WITH A SUITABLE COMBINATION OF EDUCATION, TRAINING AND EXPERIENCEbr H.10B Must have BS in Regulatory Affairs, Pharmacy, or related field and 5 years of experience with clinical data management in the pharmaceuticalbiotech industry. We will also accept an MS and 3 years of experience with clinical data management in the pharmaceuticalbiotech industry. Experience must include working with the followingbr clinical drug development through Phase 3 in an outsourced CRO model; eClinical processes, efficient designbuild of an EDC data management system and other Clinical TrialData Management Systems; regulations and industryadopted data standards such as CDISC, SDTM, and CDASH; Oracle InForm, Medidata Rave or other major EDC systems; standardized medical terminology, including MedDRA and WHODrug; ICH GCP; regulatorybr requirements and expectations for clinical data systems including 21 CFR Part 11.br PLEASE NOTE that the requirements bear a reasonable relationship to the occupation of Clinical Data Manager in the context of the pharmaceutical industry and are essential to perform the job in a reasonable manner. All of our Senior Clinical Data Managers have at least the education and experience listed in the minimum requirements, and we would not hire anyone who did not possess these credentials. This employee must have the in depth, complex, and theoretical understanding of clinical data management and regulations, gained through a university degree, in order to provide the level of analysis and support required of this position. As this employee is responsible for acting as lead study data manager in support of clinical studies, his technical skills must be excellent. Because of the nature of this position, the advanced responsibilities it entails, the highly specialized duties specific to the tightly regulated pharmaceutical industry, and the serious consequences of any data handling errors in our pharmaceutical research and studies, we have determined that a combination of a university education and extensive handson experience is necessary. Specifically, we have determined that a Masters degree and 3 years of experience, or a Bachelors degree and 5 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

2022-01-18

SWA Job Order End Date

2022-02-18

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2022-01-23

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-01-30

Employer Website From Date

2022-01-14

Employer Website To Date

2022-01-28

Professional Organization Ad From Date

2022-01-19

Professional Organization Advertisement To Date

2022-02-18

Job Search Website From Date

2022-01-19

Job Search Website To Date

2022-02-22

Employee Referral Program From Date

2023-01-01 17:57:42

Employee Referral Program To Date

2023-01-01 17:57:42

Local Ethnic Paper From Date

2023-01-01 17:57:42

Local Ethnic Paper To Date

2023-01-01 17:57:42

Radio/TV Ad From Date

2023-01-01 17:57:42

Radio/TV Ad To Date

2023-01-01 17:57:42

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

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

NORTHEASTERN UNIVERSITY

Foreign Worker Education Institution Address 1

271 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

hbc@rsstlawgroup.com

Employer Information Declaration Name

Casey Hall

Employer Information Declaration Title

Talent Acquisition Manager