Employer Contact Country :UNITED STATES OF AMERICA
Employer Contact Post Code:30096
Employer Contact Phone:6783101230
Employer Contact Email:immigration@acsicorp.com
Attorney
Agent/ Attorney Name:Krista L Carpenter
Agent/ Attorney Firm Name:Piston Carpenter P.C.
Agent/ Attorney Phone:248-680-0600
Agent/ Attorney Phone Ext.:
Agent/ Attorney Address Line 1:314 Town Center Drive
Agent/ Attorney Address Line 2:
Agent/ Attorney City:Troy
Agent/ Attorney State/ Province:MICHIGAN
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:48084
Agent/ Attorney Email:greencard@piston.net
Position Info
Prevailing Wage Track Number:P10021090187958
Prevailing Wage SOC Code :13-1041
Prevailing Wage SOC Title :Regulatory Affairs Specialist
Prevailing Wage Skill Level:Level II
Prevailing Wage:54850
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-08-31
Prevailing Wage Expiration Date :2022-06-30
Wage Offer From:114400
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:2400 Meadowbrook Parkway
Worksite Address Line 2:
Worksite City :Duluth
Worksite State:GEORGIA
Worksite Postal Code:30096
Job Title:Regulatory Affairs Associate
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:Regulatory Affairs
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :Y
Required Expreience Months :12
Accept Alternate Field of Study:Y
Accept Alternate Major:a related field
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:12
Accept Alternate Job Title:a related occupation
Normal Requirements of Job Opportunity:Y
Required Foreign Language:N
Specific Skills:Related experience must include experience publishing new and ongoing clinical studies for disclosure on National Institute of Health NIH Protocol Registration System PRS, publicly available as ClinicalTrials.gov CTgov, providing regulatory guidance to operational partners Biostatisticians in developing adhoc reports for data sharing and clinical trial results reporting on CTgov and EUCTR, processing the documentation for facilities, processes, and systems as required by the current Good Laboratory Practices GLP andor Good Manufacturing Practices cGMP regulations and as required by the International Standards, serve as tactical liaison to multiple functional areas, including key study personal and system owners, developing accurate reports, ensuring that information meets the business needs and interpreting data from complex sources including statistical analysis plans, tables, listings and figures TLFs to develop clinical study results data to be published in summary tables. All employment offers require completion of a criminal background check.br Telecommuting is available.
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:2021-07-15
Job Oder End Date:2021-08-16
Sunday Edition Newspaper:Y
First Newspaper Name:The Atlanta JournalConstitution
First Advertisement Start Date:2021-08-22
Second Newspaper Name:The Atlanta JournalConstitution
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-08-29
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:2021-07-13
Job Search Website to Date:2021-08-13
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:2021-07-20
Employee Referral Program to Date:2021-08-03
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:
Local Ethnic Newspaper to Date:
Radio/TV Ad from Date:2021-08-27
Radio/TV Ad to Date:2021-08-27
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 FOR DRUGS, BIOLOGICS MEDICAL DEVICES
Year of Compelted Education:2013
Foreign Worker Istitution of Eduation:NORTHEASTERN UNIVERSITY
Foreign Worker Education Instution Address Line 1:360 HUNTINGTON AVE
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
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:Krista L Carpenter
Preparer Title:Attorney
Preparer Email :greencard@piston.net
Employer Information Declaration Name:Promod Vohra
Employer Declaration Title:Chief HR and Talent Strategy Officer
