Prevailing Wage SOC Title :Regulatory Operations Lead
Prevailing Wage Skill Level:Level IV
Prevailing Wage:104915
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2019-06-07
Prevailing Wage Expiration Date :2019-09-05
Wage Offer From:104915
Wage Offer To:160000
Wage Offer Unit of Pay:Year
Workstie Address Line 1:50 Binney Street
Worksite Address Line 2:
Worksite City :Cambridge
Worksite State:MASSACHUSETTS
Worksite Postal Code:2142
Job Title:Regulatory Operations Lead
Minimum Education:Bachelor's
Other Degree/ Diploma:
Major Field of Study:Biotechnology
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :Y
Required Expreience Months :72
Accept Alternate Field of Study:Y
Accept Alternate Major:Laboratory Sciences
Alternate Combination of Education/ Experience:Y
Required Alternate Level of Education :Master's
Other Alternate Level of Education:
Acceptable Years of Experience:4
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:72
Accept Alternate Job Title:Regulatory Operations
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:FOUR 4 YEARS OF EXPERIENCE WITH THE FOLLOWING EXPERIENCE MAY BE GAINED CONCURRENTLYbr EXPERIENCE WITH REGULATORY PROCESSES AND SYSTEMS;br PHARMACEUTICAL, BIOTECHNOLOGY REGULATORY OPERATIONS INDUSTRY EXPERIENCE;br KNOWLEDGE OF GLOBAL ICH INTERNATIONAL COUNCIL FOR HARMONIZATION GUIDELINES AS THEY PERTAIN TO ECTD ELECTRONIC COMMON TECHNICAL DOCUMENT PUBLISHING AND SUBMISSIONS.br br THREE 3 YEARS OF EXPERIENCE WITH THE FOLLOWING EXPERIENCE MAY BE GAINED CONCURRENTLYbr EXPERIENCE IN CUSTOMER AND BUSINESS RELATIONSHIP MANAGEMENT;br KNOWLEDGE OF NEES NONECTD ELECTRONIC SUBMISSIONS SUBMISSION GUIDELINES;br EXPERIENCE MANAGING CROS CONTRACT RESEARCH ORGANIZATIONS;br DOCUMENT MANAGEMENT AND PUBLISHING SYSTEMS AND ANY RELATED SUPPORT TOOLS SUCH AS LORENZ EVALIDATOR OR ISI TOOLBOX;br KNOWLEDGE OF ANY REGIONAL REQUIREMENTSGUIDELINES FOR GEM PUBLISHING AND SUBMISSIONS.br br WILL ACCEPT ANY SUITABLE EQUIVALENT COMBINATION OF EDUCATION, TRAINING, AND EXPERIENCE.br br POSITION OFFERS OPTION TO TELECOMMUTE FROM A HOME OFFICE AND WAS ADVERTISED AS SUCH.
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:2019-10-21
Job Oder End Date:2019-11-20
Sunday Edition Newspaper:Y
First Newspaper Name:Boston Globe
First Advertisement Start Date:2019-10-20
Second Newspaper Name:Boston Globe
Second Advertisement Type:Newspaper
Second Ad Start Date:2019-10-27
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:
Employer Website to Date:
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2019-10-22
Job Search Website to Date:2019-11-05
Private Employment Firm from Date:2019-08-28
Pricate Employment Firm to Date:2019-09-04
Employee Referral Program from Date:
Employee Referral Program to Date:
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:
Local Ethnic Newspaper to Date:
Radio/TV Ad from Date:2019-11-20
Radio/TV Ad to Date:2019-11-20
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:CLINICAL LABORATORY SCIENCES
Year of Compelted Education:2013
Foreign Worker Istitution of Eduation:UNIVERSITY OF MASSACHUSETTS
Foreign Worker Education Instution Address Line 1:220 PAWTUCKET STREET
Foreign Worker Education Institution Address Line 2:
Foreign Worker Education Institution City:LOWELL
Foreign Worker Educatution Institution State:MA
Foreign Worker Education Institution Country :UNITED STATES OF AMERICA
Foreign Worker Education Training Post Code:1854
Foreign Worker Training Completion :N/A
Foreign Worker Required Experience :N
Foreign Worker Alternate Education and Experience :Y
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:Liya Green
Preparer Title:Associate
Preparer Email :greenl@hunton.com
Employer Information Declaration Name:Janet L DErrico