All Details of Green Card Application:
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Case Number: A-20205-79868
Fiscal year: 2021
Fiscal Year
2021
Case Number
A-20205-79868
Case Status
Certified-Expired
Received Date
2020-07-23
Decision Date
2021-03-03
Refile
N
Original File Date
2021-01-01 09:04:37
Previous SWA Case Number State
Schedule A Sheepherder
N
Employer Name
SHIRE HUMAN GENETIC THERAPIES SHGT INC
Employer Name Slug
shire-human-genetic-therapies-shgt-inc
Employer Address 1
300 SHIRE WAY
Employer Address 2
Employer City
LEXINGTON
Employer City Slug
lexington
Employer State
MASSACHUSETTS
Employer State Slug
massachusetts
Employer Country
UNITED STATES OF AMERICA
Employer Postal Code
2421
Employer Phone
781-482-0599
Employer Number of Employees
49578
Employer Year Commenced Business
1994
NAICS Code
325412
FW Ownership Interest
N
Employer Contact Name
Patty Chookhae-Kragh
Employer Contact Address 1
650 East Kendall 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
617-588-8463
Employer Contact Email
patty.chookhae-kragh@shire.com
Agent Attorney Name
Susie Shin
Agent Attorney Firm Name
Zulkie Partners LLC
Agent Attorney Phone
(312) 831-2127
Agent Attorney Address 1
135 South La Salle Street
Agent Attorney Address 2
Suite 3425
Agent Attorney City
Chicago
Agent Attorney State/Province
ILLINOIS
Agent Attorney Country
UNITED STATES OF AMERICA
Agent Attorney Postal Code
60603
Agent Attorney Email
sshin@zulkiepartners.com
PW Track Number
P10019228041594
PW SOC Code
11-9199
PW SOC Title
Regulatory Affairs Managers
PW Skill Level
Level II
PW Wage
104021.00
PW Unit of Pay
Year
PW Wage Source
OES
PW Determination Date
2019-12-13
PW Expiration Date
2020-06-30
Wage Offer From
142700.00
Wage Offer To
214000.00
Average Salary
178350.00
Wage Unit of Pay
Year
Worksite Address 1
650 E. Kendall Street
Worksite Address 2
Worksite City
Cambridge
Worksite City Slug
cambridge
Worksite State
MASSACHUSETTS
Worksite Postal Code
2142
Job Title
Manager, Regulatory Labeling Strategy
Job Title Slug
manager-regulatory-labeling-strategy
Minimum Education
Bachelor's
Major Field of Study
Chemistry, Pharmacy or closely related field
Required Training
N
Required Experience
N
Required Experience Months
Accept Alternative Field of Study
N
Accept Alternative Major Field of Study
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
36
Accept Alternative Job Title
Jr Labeling Lead or rltd pstn
Job Opportunity Requirements Normal
N
Foreign Language Required
N
Specific Skills
WILL ACCEPT ANY LEVEL OF EXPERIENCE IN THE FOLLOWING SKILLS PROVIDE LABELING STRATEGY BY ASSESSING GLOBALLOCAL LABELING REGULATIONS, COMPETITOR LABELING, LABELING TRENDS, COLLATING HISTORICAL HEALTH AUTHORITY FEEDBACK, AND COMPANY INTERNAL DATA TO OPTIMIZE THE PRODUCT LABELING FOR THE BENEFIT OF THE PATIENT; AUTHORREVIEWUPDATE COMPANY CORE DATA SHEET CCDS, CORE SAFETY INFORMATION CCSI, REFERENCE SAFETY INFORMATION RSI, REGIONALLOCAL LABELING USPI AND EU SMPC AND SUPPORTING DOCUMENTATION WITH SAFETYNONSAFETY DATA IN COORDINATION WITH LABELING TEAMS FOR PRESENTATION TO LABELING GOVERNANCE COMMITTEES FOR ENDORSEMENT OR APPROVAL;PREPARE RESPONSE DOCUMENTS AND BACKUP STRATEGIES FOR LABEL NEGOTIATIONS WITH HEALTH AUTHORITIES TO ADDRESS THE LABELINGRELATED QUERIES BY INTERPRETING CLINICAL AND SCIENTIFIC DATA FROM CLINICAL STUDY REPORTS, SAFETY SUMMARIES, TOXICOLOGY REPORTS, CHEMISTRYMANUFACTURING REPORTS AND OTHER SOURCES; MANAGE ALL TYPES OF LABELING DOCUMENTCOMPONENTS AND OTHER INFORMATION IN THE RELEVANT ELECTRONIC DOCUMENT MANAGEMENT SYSTEMS SUCH AS FIRST DOC, LABELING TRACKING SYSTEM, SHAREPOINT FOR REGULATORY COMPLIANCE.
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
2020-05-20
SWA Job Order End Date
2020-06-22
Sunday Edition Newspaper
Y
First Newspaper Name
The Boston Globe
First Advertisement Start Date
2020-05-31
Second Newspaper Ad Name
The Boston Globe
Second Advertisement Type
Newspaper
Second Ad Start Date
2020-06-07
Employer Website From Date
2020-05-20
Employer Website To Date
2020-06-22
Professional Organization Ad From Date
2021-01-01 09:04:37
Professional Organization Advertisement To Date
2021-01-01 09:04:37
Job Search Website From Date
2020-05-31
Job Search Website To Date
2020-06-14
Employee Referral Program From Date
2020-05-19
Employee Referral Program To Date
2020-06-22
Local Ethnic Paper From Date
2021-01-01 09:04:37
Local Ethnic Paper To Date
2021-01-01 09:04:37
Radio/TV Ad From Date
2021-01-01 09:04:37
Radio/TV Ad To Date
2021-01-01 09:04:37
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
Bachelor's
Foreign Worker Information: Major
PHARMACY
Foreign Worker Years of Education Completed
2013
Foreign Worker Institution of Education
UNIVERSITY OF PUNE
Foreign Worker Education Institution Address 1
GANESHKHIND RD
Foreign Worker Education Institution Address 2
Foreign Worker Education Institution City
PUNE
Foreign Worker Education Institution State/Province
MAHARASTRA
Foreign Worker Education Institution Country
INDIA
Foreign Worker Education Institution Postal Code
411007
Foreign Worker Experience with Employer
N
Foreign Worker Employer Pays for Education
N
Foreign Worker Currently Employed
Y
Employer Completed Application
N
Preparer Name
Susie Shin
Preparer Title
Principal
Preparer Email
sshin@zulkiepartners.com
Employer Information Declaration Name
Paul Lambert
Employer Information Declaration Title
Global Mobility Manager