TAKEDA DEVELOPMENT CENTER AMERICAS, INC.

Good Clinical Practice Compliance Manager

A-22270-28819 TN 2023 Certified

Salary

$168,210

Visa Type

Job Title

Good Clinical Practice Compliance Manager

Employee's Citizenship

MEXICO

Graduate School

UNIVERSIDAD AUTONOMA DEL ESTADO DE MEXICO

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22270-28819

Case Status Certified

Received Date 2022-10-21

Decision Date 2023-09-18

Refile N

Original File Date -

Previous State Work Force Agency (SWA) Case Number Stete -

Schedule A or a Sheepherder Occupation N

Company Info

14 fields

Employer Name TAKEDA DEVELOPMENT CENTER AMERICAS, INC.

Employer Address_Line 1 95 HAYDEN AVE

Employer Address_Line 2 -

Employer City LEXINGTON

State -

Employer State/ Province MASSACHUSETTS

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 2421

Employer Phone No. 224-544-1749

Employer Phone Extent No. -

Total Number of Employees 19608

Employer Year of Commenced 2003

NAICS Code 325412

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Ken Brown

Employer Contact Address Line1 95 Hayden Ave

Employer Contact Address Line2 -

Employer Contact City Lexington

Employer Contact State/ Provice MASSACHUSETTS

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 2421

Employer Contact Phone 617-794-2549

Employer Contact Email ken.brown@takeda.com

Attorney

11 fields

Agent/ Attorney Name Susie Shin

Agent/ Attorney Firm Name Zulkie Partners LLC

Agent/ Attorney Phone (312) 831-2127

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 135 South La Salle Street

Agent/ Attorney Address Line 2 Ste. 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

Position Info

89 fields

Prevailing Wage Track Number P10021307684469

Prevailing Wage SOC Code 11-9199

Prevailing Wage SOC Title Regulatory Affairs Manager

Prevailing Wage Skill Level Level IV

Prevailing Wage 168210

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-05-11

Prevailing Wage Expiration Date 2022-08-09

Wage Offer From 170200

Wage Offer To 197100

Wage Offer Unit of Pay Year

Workstie Address Line 1 40 Landsdowne St.

Worksite Address Line 2 -

Worksite City Cambridge

Worksite State MASSACHUSETTS

Worksite Postal Code 2139

Job Title Good Clinical Practice Compliance Manager

Minimum Education Bachelor's

Other Degree/ Diploma -

Major Field of Study Chemistry, Biology or related field

Required Training N

Required Training Month -

Required Field of Training -

Required Experience N

Required Expreience Months -

Accept Alternate Field of Study N

Accept Alternate Major -

Alternate Combination of Education/ Experience N

Required Alternate Level of Education -

Other Alternate Level of Education -

Acceptable Years of Experience -

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 60

Accept Alternate Job Title PHARMA BUSINESS SYSTEM ANALYST OR RELATED

Normal Requirements of Job Opportunity N

Required Foreign Language N

Specific Skills Prior experience must include Knowledge andor awareness of applicable global regulations i.e. United States Food and Drug Administration, European Medicines Agency, etc. and guidance related to the submission and approval of innovative medicines. Knowledge in the conduct and reporting of internal corporate audits and the translation of findings into corrective and preventive action plans. Experience in management of drug related investigations and deviations to address root causes and corrective and preventive actions related to critical and major issues for drug development. Management of Health Authority audits to address questions and fulfill document requests which are raised by inspectors.

Combination Occupation N

Offered to Applied Foreign Worker Y

ForeignWorker Live on Premises N

Live in Domestic Service Worker N

Employment Contract -

Professional Occupation Y

College/ University Teacher N

Competitive Process -

Basic Recruitment Process -

Teacher Select Date -

Teacher Publish Journal Name -

Additional Recruitment Information -

Job Oder Start Date 2022-06-03

Job Oder End Date 2022-07-11

Sunday Edition Newspaper Y

First Newspaper Name Boston Sunday Globe

First Advertisement Start Date 2022-06-05

Second Newspaper Name Boston Sunday Globe

Second Advertisement Type Newspaper

Second Ad Start Date 2022-06-12

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date 2022-06-03

Employer Website to Date 2022-09-20

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-09-07

Job Search Website to Date 2022-09-19

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date -

Employee Referral Program to Date -

Campus Placement from Date -

Campus Placement to Date -

Local Ethnic Newspaper from Date 2022-06-09

Local Ethnic Newspaper to Date 2022-06-09

Radio/TV Ad from Date -

Radio/TV Ad to Date -

Employer Received the Payment N

Payment Details -

Bargaining Representative Notified N/A

Posted Notice at Worksite Y

Layoff in Past Six Months N

US Worker Considered -

Country of Citizenship MEXICO

Foreign Worker Birth Country MEXICO

Class of Admission TN

Employee Info

24 fields

Foreign Worker Education Bachelor's

Foreign Worker Education Other -

Foreign Worker Major CHEMISTRY, PHARMACEUTICAL SCIENCE AND BIOLOGY

Year of Compelted Education 2000

Foreign Worker Istitution of Eduation UNIVERSIDAD AUTONOMA DEL ESTADO DE MEXICO

Foreign Worker Education Instution Address Line 1 PASEO COLN SN, RESIDENCIAL COLN Y COL CIPRS

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City TOLUCA

Foreign Worker Educatution Institution State ESTADO DE MEXICO

Foreign Worker Education Institution Country MEXICO

Foreign Worker Education Training Post Code 50120

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N/A

Foreign Worker Alternate Education and Experience N/A

Foreign Worker Alternate Occupation Experience Y

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay 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 Ken Brown

Employer Declaration Title Global Mobility Strategy Lead