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Case Number: A-20272-05014

Fiscal year: 2021

Fiscal Year

2021

Case Number

A-20272-05014

Case Status

Certified

Received Date

2020-10-28

Decision Date

2021-05-03

Refile

N

Original File Date

2021-01-01 09:19:01

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Ionis Pharmaceuticals, Inc.

Employer Name Slug

ionis-pharmaceuticals-inc

Employer Address 1

2855 Gazelle Ct.

Employer Address 2

Employer City

Carlsbad

Employer City Slug

carlsbad

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

92010

Employer Phone

7609319200

Employer Number of Employees

523

Employer Year Commenced Business

1989

NAICS Code

541710

FW Ownership Interest

N

Employer Contact Name

Shannon Devers

Employer Contact Address 1

2855 Gazelle Ct.

Employer Contact Address 2

Employer Contact City

Carlsbad

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

92010

Employer Contact Phone

7609319200

Employer Contact Email

[email protected]

Agent Attorney Name

Sharon R Mehlman

Agent Attorney Firm Name

Tafapolsky Smith Mehlman LLP

Agent Attorney Phone

8584126300

Agent Attorney Address 1

P.O. Box 928800

Agent Attorney Address 2

Agent Attorney City

San Diego

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

921928800

Agent Attorney Email

[email protected]

PW Track Number

P10020121532224

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level III

PW Wage

79186.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-08-17

PW Expiration Date

2021-06-30

Wage Offer From

93422.00

Wage Offer To

0.00

Average Salary

93422.00

Wage Unit of Pay

Year

Worksite Address 1

2855 GAZELLE COURT

Worksite Address 2

Worksite City

CARLSBAD

Worksite City Slug

carlsbad

Worksite State

CALIFORNIA

Worksite Postal Code

92010

Job Title

CMC Manager (Regulatory Affairs)

Job Title Slug

cmc-manager-regulatory-affairs

Minimum Education

Bachelor's

Major Field of Study

Pharmaceutical Sciences, *See H.14

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

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

48

Accept Alternative Job Title

Regulatory Affairs in the pharmaceutical industry See H.14

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

In H.4 and H.4B above, the education requirement is a Bachelors degree or equivalent in Pharmaceutical Sciences, Pharmacy, Organic Chemistry, Chemical Engineering, Biochemistry or related field.br br In H.10B above, the experience requirement is four 4 years of experience in Regulatory Affairs in the pharmaceutical industry.br br Special Requirements Academic or work experience to include Experience with drafting, reviewing and submitting common technical documents for clinical andor commercial pharmaceutical products in the US andor globally; Knowledge of change management requirements for pharmaceutical applications, including identifying and classifying the change, and preparation of the appropriate submission documents; Experience utilizing electronic regulatory management systems for compiling, tracking, and managing regulatory submissions e.g. Veeva, Documentum as well as ability to configure a system to accommodate new requirements; Project management skills related to ensuring annual reporting requirements are adhered to, commitments made to regulatory agencies are completed within agreed to time frames, and all companyrelated submission timelines are met.br br Special requirements defined at H.14 not to be conflated with H.10A. There is no timing requirement associated with the special requirements defined at H.14, unless specifically stated otherwise.br br In F.2 above, the six digit code is assigned based on the extension 131041.07 Regulatory Affairs Specialists.

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

2020-08-21

SWA Job Order End Date

2020-09-25

Sunday Edition Newspaper

Y

First Newspaper Name

San Diego Union Tribune

First Advertisement Start Date

2020-09-13

Second Newspaper Ad Name

San Diego Union Tribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-09-20

Employer Website From Date

2020-08-28

Employer Website To Date

2020-09-04

Professional Organization Ad From Date

2021-01-01 09:19:01

Professional Organization Advertisement To Date

2021-01-01 09:19:01

Job Search Website From Date

2020-09-15

Job Search Website To Date

2020-09-22

Employee Referral Program From Date

2021-01-01 09:19:01

Employee Referral Program To Date

2021-01-01 09:19:01

Local Ethnic Paper From Date

2020-09-18

Local Ethnic Paper To Date

2020-09-18

Radio/TV Ad From Date

2021-01-01 09:19:01

Radio/TV Ad To Date

2021-01-01 09:19:01

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

Bachelor's

Foreign Worker Information: Major

PHARMACEUTICAL SCIENCE

Foreign Worker Years of Education Completed

2011

Foreign Worker Institution of Education

UNIVERSITY OF MUMBAI

Foreign Worker Education Institution Address 1

CHM CAMPUS

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

ULHASNAGAR

Foreign Worker Education Institution State/Province

MAHARASHTRA

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

421003

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Sharon R Mehlman

Preparer Title

Partner, Attorney at Law

Preparer Email

[email protected]

Employer Information Declaration Name

Shannon L Devers

Employer Information Declaration Title

Vice President, Human Resources