Fiscal Year

2022

Case Number

A-21281-56098

Case Status

Certified

Received Date

2021-10-22

Decision Date

2022-04-28

Refile

N

Original File Date

2022-01-01 11:21:20

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

PPD DEVELOPMENT, L.P.

Employer Name Slug

ppd-development-lp

Employer Address 1

929 NORTH FRONT ST

Employer Address 2

Employer City

WILMINGTON

Employer City Slug

wilmington

Employer State

NORTH CAROLINA

Employer State Slug

north-carolina

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

28401

Employer Phone

910-251-0081

Employer Number of Employees

22500

Employer Year Commenced Business

1985

NAICS Code

5417

FW Ownership Interest

N

Employer Contact Name

Kyle Nance

Employer Contact Address 1

929 North Front Street

Employer Contact Address 2

Employer Contact City

Wilmington

Employer Contact State/Province

NORTH CAROLINA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

28401

Employer Contact Phone

9194565578

Employer Contact Email

GlobalMobility.sm@ppdi.com

Agent Attorney Name

Whitney L Brownlow

Agent Attorney Firm Name

Ogletree, Deakins, Nash, Smoak Stewart, P.C.

Agent Attorney Phone

9197879700

Agent Attorney Address 1

8529 Six Forks Road

Agent Attorney Address 2

Forum IV, Suite 600

Agent Attorney City

Raleigh

Agent Attorney State/Province

NORTH CAROLINA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

27615

Agent Attorney Email

Whitney.Brownlow@ogletreedeakins.com

PW Track Number

P10020356973612

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

77147.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-05-06

PW Expiration Date

2021-08-04

Wage Offer From

118219.00

Wage Offer To

0.00

Average Salary

118219.00

Wage Unit of Pay

Year

Worksite Address 1

929 North Front Street

Worksite Address 2

Worksite City

Wilmington

Worksite City Slug

wilmington

Worksite State

NORTH CAROLINA

Worksite Postal Code

28401

Job Title

Regulatory Affairs Manager

Job Title Slug

regulatory-affairs-manager

Minimum Education

Master's

Major Field of Study

Health-related field

Required Training

N

Required Experience

Y

Required Experience Months

84

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

9

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

84

Accept Alternative Job Title

Regulatory Affairs Specialist, Regulatory Affairs Manager, Regulatory Affairs Director, or a related

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Seven 7 years of experience with Leading global regulatory affairs for clinical trials in North America, Latin America, Caribbean, EMEA, and APAC markets; Working in a regulatory specialty area, such as preclinical, clinical, CMC, publishing, or similar; ICH and global regulatory guidelines; Global, regional, and national requirements and regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management; and Project Management. Five 5 years of experience with Medical terminology, statistical concepts, and guidelines; Budgeting and forecasting; and Microsoft Office Suite, including Word, Excel, and PowerPoint.

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

2021-06-08

SWA Job Order End Date

2021-07-09

Sunday Edition Newspaper

Y

First Newspaper Name

Wilmington StarNews

First Advertisement Start Date

2021-06-13

Second Newspaper Ad Name

Wilmington StarNews

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-06-20

Employer Website From Date

2021-06-04

Employer Website To Date

2021-06-18

Professional Organization Ad From Date

2022-01-01 11:21:20

Professional Organization Advertisement To Date

2022-01-01 11:21:20

Job Search Website From Date

2021-06-04

Job Search Website To Date

2021-06-18

Employee Referral Program From Date

2022-01-01 11:21:20

Employee Referral Program To Date

2022-01-01 11:21:20

Local Ethnic Paper From Date

2022-01-01 11:21:20

Local Ethnic Paper To Date

2022-01-01 11:21:20

Radio/TV Ad From Date

2021-06-14

Radio/TV Ad To Date

2021-06-14

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

MEXICO

Foreign Worker Birth Country

MEXICO

Class of Admission

L-1

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

NUTRITION HEALTHRELATED FIELD

Foreign Worker Years of Education Completed

2004

Foreign Worker Institution of Education

UNIVERSIDAD IBEROAMERICANA

Foreign Worker Education Institution Address 1

PROLONGACION PASEO DE LA REFORMA 880

Foreign Worker Education Institution Address 2

LOMAS DE SANTA FE, ALVARO OBREGON

Foreign Worker Education Institution City

CIUDAD DE MEXICO

Foreign Worker Education Institution State/Province

Foreign Worker Education Institution Country

MEXICO

Foreign Worker Education Institution Postal Code

1219

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Whitney L Brownlow

Preparer Title

Attorney

Preparer Email

Whitney.Brownlow@ogletree.com

Employer Information Declaration Name

Kyle Nance

Employer Information Declaration Title

Associate Manager