Fiscal Year

2021

Case Number

A-20188-73185

Case Status

Certified-Expired

Received Date

2020-07-10

Decision Date

2021-02-24

Refile

N

Original File Date

2021-01-01 09:03:13

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Pharmacyclics, LLC

Employer Name Slug

pharmacyclics-llc

Employer Address 1

995 East Arques Avenue

Employer Address 2

Employer City

Sunnyvale

Employer City Slug

sunnyvale

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

94085

Employer Phone

408-215-3000

Employer Number of Employees

715

Employer Year Commenced Business

1991

NAICS Code

541711

FW Ownership Interest

N

Employer Contact Name

Megan A Downey

Employer Contact Address 1

995 East Arques Avenue

Employer Contact Address 2

Employer Contact City

Sunnyvale

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

94085

Employer Contact Phone

408-215-3012

Employer Contact Email

mdowney@pcyc.com

Agent Attorney Name

Lisa Spiegel

Agent Attorney Firm Name

Duane Morris LLP

Agent Attorney Phone

(415) 957-3069

Agent Attorney Address 1

One Market Plaza, Spear Twr

Agent Attorney Address 2

Ste 2200

Agent Attorney City

San Francisco

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

94105-1127

Agent Attorney Email

lspiegel@duanemorris.com

PW Track Number

P10019190018068

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level III

PW Wage

95389.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-10-24

PW Expiration Date

2020-06-30

Wage Offer From

95389.00

Wage Offer To

0.00

Average Salary

95389.00

Wage Unit of Pay

Year

Worksite Address 1

999 East Arques Avenue

Worksite Address 2

Worksite City

Sunnyvale

Worksite City Slug

sunnyvale

Worksite State

CALIFORNIA

Worksite Postal Code

94085

Job Title

Sr. Specialist, Regulatory Operations

Job Title Slug

sr-specialist-regulatory-operations

Minimum Education

Master's

Major Field of Study

Biomedical Engineering or related field

Required Training

N

Required Experience

Y

Required Experience Months

12

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Biomedical Engineering or related field

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

12

Accept Alternative Job Title

as a Regulatory Affairs Specialist

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

RAC certification. SkillsPreparation of regulatory submissions to US FDA, EMA and Health Canada for pharmaceutical and biologic products; CTDeCTD submissions; implement SOPs for regulatory strategy and regulatory operations; technical writing involving clinical trial applications; regulatory research and discovery; INDs, CTAs, NDAs and BLAs; use of ISItoolbox and Lorenz docuBridge, andVeera Vauult; MS Excel; eCTDXpress; MS PowerPoint, Visio and Word; IB, PAS, DSUR and CBEs. Hiring Requirements Background Reference Checks.

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

2020-05-04

SWA Job Order End Date

2020-06-04

Sunday Edition Newspaper

Y

First Newspaper Name

San Jose Mercury NewsBay Area News Group

First Advertisement Start Date

2020-04-26

Second Newspaper Ad Name

San Jose Mercury NewsBay Area News Group

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-05-03

Employer Website From Date

2021-01-01 09:03:13

Employer Website To Date

2021-01-01 09:03:13

Professional Organization Ad From Date

2021-01-01 09:03:13

Professional Organization Advertisement To Date

2021-01-01 09:03:13

Job Search Website From Date

2020-05-07

Job Search Website To Date

2020-05-15

Employee Referral Program From Date

2020-05-26

Employee Referral Program To Date

2020-06-09

Local Ethnic Paper From Date

2020-05-01

Local Ethnic Paper To Date

2020-05-01

Radio/TV Ad From Date

2021-01-01 09:03:13

Radio/TV Ad To Date

2021-01-01 09:03:13

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

INDIA

Foreign Worker Birth Country

INDIA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

BIOMEDICAL ENGINEERING

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

UNIVERSITY OF FLORIDA

Foreign Worker Education Institution Address 1

GAINESVILLE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

GAINESVILLE

Foreign Worker Education Institution State/Province

FL

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

32611

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Lisa Spiegel

Preparer Title

Partner

Preparer Email

lspiegel@duanemorris.com

Employer Information Declaration Name

Megan Downey

Employer Information Declaration Title

HR Operations and Programs Specialist