Fiscal Year

2024

Case Number

A-23059-06882

Case Status

Certified

Received Date

2023-02-28

Decision Date

2024-03-20

Refile

N

Original File Date

2024-01-01 01:00:50

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

EDWARDS LIFESCIENCES LLC

Employer Name Slug

edwards-lifesciences-llc

Employer Address 1

ONE EDWARDS WAY

Employer Address 2

Employer City

IRVINE

Employer City Slug

irvine

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

92614

Employer Phone

(949) 250-6338

Employer Number of Employees

16000

Employer Year Commenced Business

2000

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Diana Fernando

Employer Contact Address 1

One Edwards Way

Employer Contact Address 2

Employer Contact City

Irvine

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

92614

Employer Contact Phone

(949) 250-2350

Employer Contact Email

Diana_Fernando@edwards.com

Agent Attorney Name

Diana V Coker

Agent Attorney Firm Name

Larrabee Albi Coker LLP

Agent Attorney Phone

(858) 642-0420

Agent Attorney Address 1

P.O. Box 919016

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

92191-9016

Agent Attorney Email

Diana@larrabee.com

PW Track Number

P10022138183196

PW SOC Code

27-3042.00

PW SOC Title

Technical Writers

PW Skill Level

Level IV

PW Wage

103917.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2023-02-14

PW Expiration Date

2023-06-30

Wage Offer From

175000.00

Wage Offer To

0.00

Average Salary

175000.00

Wage Unit of Pay

Year

Worksite Address 1

100 telecommute position reporting to One Edwards Way

Worksite Address 2

Worksite City

Irvine

Worksite City Slug

irvine

Worksite State

CALIFORNIA

Worksite Postal Code

92614

Job Title

Manager, Medical Writing

Job Title Slug

manager-medical-writing

Minimum Education

Doctorate

Major Field of Study

Sciences (Pharmaceutical, Chemical) or a related field

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

See H.4B

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

6

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

36

Accept Alternative Job Title

medical writing, clinical documents research or processing contd in H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Contd from F.18 Employer filed a separate wage request P10022138183189 to address the Bachelors degree based alternative. The wage determination is valid from 02142023 through 6302023; wage level 4 103,917.00 was assigned.br br Contd from H.8 In lieu of a PhD and 3 years of experience, employer will accept EITHER a Masters degree or equivalent in Sciences Pharmaceutical, Chemical or a related field and 6 years of experience in medical writing, clinical documents research or processing, or a combination of these fields OR a Bachelors degree or equivalent in Sciences Pharmaceutical, Chemical or a related field and 8 years of progressive experience in medical writing, clinical documents research or processing, or a combination of these fields. All experience must be in the medical device industry.br br Contd from H.10B or a combination of these fields; experience must be in the medical device industry.br br Contd from H.12 Job requirements are normal for the employer due to the complexity of job duties associated with this position. Employer answered no to Question H.12 based on SVP analysis only.br br Work experience to include 1. Authoring and developing CERs Clinical Evaluation Reports. 2. Conducting discussions and presentations on the following scientific and technical subjects with stakeholders EU MDD European Medical Device Directive, EU MDR European Medical Device Regulations, CEP Clinical Evaluation Plans, and CERs Clinical Evaluation Reports, or any combination of thereof in compliance with the following regulations or guidelines MDD 9342EEC as amended by 200747EC; MED DEV 2.71, rev. 4; MDR 2017745, MDCG 20201, MDCG 20205, and MDCG 20206. 3. Leading or providing guidance to various teams within the organization including Medical Affairs, Scientific Communications, Regulator Affairs, Research and Development on clinical evaluation processes, literature search processes and the use of the following documents MDD 9342EEC as amended by 200747EC; MED DEV 2.71, rev. 4; MDR 2017745, MDCG 20201, MDCG 20205, and MDCG 20206. 4. Utilizing publication library software EndNote, database systems Medline or PubMed and Microsoft Office Suite Word, Excel, and PowerPoint to identify and summarize information from clinical and regulatory documentation for entering into evidence tables and reports. 5. Utilizing editing and proofreading skills to write regulatory documentation, analytical reports, and procedures related to medical writing. 6. Creating procedures and guidelines for standardizing medical writing styles and techniques. 7. Using biomedical statistics to interpret data collected from published literature and clinical trial investigation materials. 8. Using biomedical statistics to enable completion of project deliverables, including negotiating deliverable timelines, and resolving projectrelated issues with crossfunctional partners Regulatory Affairs, Quality, Clinical Project Managers, Clinical Data Management, and Biostatistics. 9. Using experience with EU Medical Device Regulations requirements to submit pre and post market reports. 10. Representing regulatory affairs leadership on clinical evaluation discussions with project managers and crossfunctional teams. 11. Providing input from the CER Clinical Evaluation Report into the following reports Postmarket Clinical Followup Plans and Reports MEDDEV 2.122, MDCG 20207, and MDCG 20208, and summary of Safety and Clinical Performance MDCG 20199; must include performing literature searches; and linking the data with any relevant documents within the manufacturers documentation or quality system.br Hiring requirements Drug TestingScreening, Background Check.

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

2022-09-26

SWA Job Order End Date

2022-10-27

Sunday Edition Newspaper

Y

First Newspaper Name

Orange County Register

First Advertisement Start Date

2022-10-09

Second Newspaper Ad Name

Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-10-16

Employer Website From Date

2024-01-01 01:00:50

Employer Website To Date

2024-01-01 01:00:50

Professional Organization Ad From Date

2024-01-01 01:00:50

Professional Organization Advertisement To Date

2024-01-01 01:00:50

Job Search Website From Date

2022-10-10

Job Search Website To Date

2022-10-16

Employee Referral Program From Date

2024-01-01 01:00:50

Employee Referral Program To Date

2024-01-01 01:00:50

Local Ethnic Paper From Date

2022-10-10

Local Ethnic Paper To Date

2022-10-10

Radio/TV Ad From Date

2024-01-01 01:00:50

Radio/TV Ad To Date

2024-01-01 01:00:50

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

Doctorate

Foreign Worker Information: Major

PHARMACEUTICAL AND CHEMICAL SCIENCE

Foreign Worker Years of Education Completed

2017

Foreign Worker Institution of Education

UNIVERSITY OF THE PACIFIC

Foreign Worker Education Institution Address 1

3601 PACIFIC AVENUE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

STOCKTON

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

95211

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Diana V Coker

Preparer Title

PartnerAttorney at Law

Preparer Email

Diana@larrabee.com

Employer Information Declaration Name

Tracie M Pham

Employer Information Declaration Title

Senior Talent Mobility Specialist