Previous State Work Force Agency (SWA) Case Number Stete:
Schedule A or a Sheepherder Occupation :N
Company Info
Employer Name:MILLENNIUM PHARMACEUTICALS, INC.
Employer Address_Line 1:40 LANDSDOWNE STREET
Employer Address_Line 2:
Employer City :CAMBRIDGE
State:
Employer State/ Province:MASSACHUSETTS
Employer Country:UNITED STATES OF AMERICA
Employer Postal Code:2139
Employer Phone No.:(617) 679-7000
Employer Phone Extent No.:
Total Number of Employees:18000
Employer Year of Commenced :
NAICS Code:325411
Foreign Worker Ownership & Interest:N
HR Info
Employer Contact Name:Paul Lambert
Employer Contact Address Line1:45 Hayden Avenue
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:617.588.8655
Employer Contact Email:paul.lambert@takeda.com
Attorney
Agent/ Attorney Name:Jennifer A Hoskin
Agent/ Attorney Firm Name:Zulkie Partners LLC
Agent/ Attorney Phone:(312) 831-2132
Agent/ Attorney Phone Ext.:
Agent/ Attorney Address Line 1:135 S LaSalle 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:kselking@zulkiepartners.com
Position Info
Prevailing Wage Track Number:P10021057105332
Prevailing Wage SOC Code :11-9199
Prevailing Wage SOC Title :Regulatory Affairs Managers
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 :2021-07-21
Prevailing Wage Expiration Date :2022-06-30
Wage Offer From:169000
Wage Offer To:240300
Wage Offer Unit of Pay:Year
Workstie Address Line 1:200 Shire Way
Worksite Address Line 2:
Worksite City :Lexington
Worksite State:MASSACHUSETTS
Worksite Postal Code:2421
Job Title:Strategist, Device Regulatory Affairs, PDT BU
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:Regulatory Affairs 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:Mgr Regulatory Affairs or rltd pstn
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:Required skills experience in IDE, PMA, Presubmission, 510k, Letter file processes and knowledge of FDA 21 CFR 820 quality system regulations 5 yrs; lead and execute regulatory activities for companion diagnostics CDx projects by collaborating with various pharmaceutical partners and create regulatory strategy for medical device submissions including Class I, II, III medical devices and companion diagnostics 2 yrs, 6 mos; knowledge of labelling registration needs and changing regulations for EU member states, China, Japan, Singapore, Malaysia, Colombia, Sri Lanka, Turkey, Saudi Arabia, Canada, India 2 yrs; conduct change control assessments and experience in Corrective and Preventive Action CAPA, Internal audits, quality training, labeling review 4 yrs; experience and working knowledge on current regulations and guidance on devices, vitro diagnostics, combination products including EU Medical Device Regulation, European Union In Vitro Device Regulation, European Norm, International Organization for Standardization including ISO 18113, EN ISO 15223, ISO 23640, ISO20916, Clinical Laboratory Improvement Amendments CLIA and ISO 15189 requirements, ISO 11608, ISO 13485, ISO 14971, ISO 10993, ISO 7864, ISO 9626, Compendia 5 yrs; identify and assess regulatory and compliance risks associated with product development and life cycle management activities. Support risk benefit analysis failure mode and effects analysis FMEA 2 yrs. 1520 national and international travel required.
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:2021-08-26
Job Oder End Date:2021-09-27
Sunday Edition Newspaper:Y
First Newspaper Name:The Boston Globe
First Advertisement Start Date:2021-08-29
Second Newspaper Name:The Boston Globe
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-09-05
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2021-08-26
Employer Website to Date:2021-09-27
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-08-29
Job Search Website to Date:2021-09-27
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:2021-08-26
Local Ethnic Newspaper to Date:2021-08-26
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:INDIA
Foreign Worker Birth Country:INDIA
Class of Admission :H-1B
Employee Info
Foreign Worker Education:Master's
Foreign Worker Education Other:
Foreign Worker Major:REGULATORY AFFAIRS
Year of Compelted Education:2014
Foreign Worker Istitution of Eduation:NORTHEASTERN UNIVERSITY
Foreign Worker Education Instution Address Line 1:360 HUNTINGTON AVENUE
Foreign Worker Education Institution Address Line 2:
Foreign Worker Education Institution City:BOSTON
Foreign Worker Educatution Institution State:MA
Foreign Worker Education Institution Country :UNITED STATES OF AMERICA
Foreign Worker Education Training Post Code:2115
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:Jennifer A Hoskin
Preparer Title:Associate
Preparer Email :jhoskin@zulkiepartners.com
Employer Information Declaration Name:Paul Lambert
