EDWARDS LIFESCIENCES LLC

Manager, Medical Writing

A-23011-85540 H-1B 2023 Withdrawn

Salary

$103,917

Visa Type

H-1B

Job Title

Manager, Medical Writing

Employee's Citizenship

INDIA

Graduate School

UNIVERSITY OF THE PACIFIC

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-23011-85540

Case Status Withdrawn

Received Date 2023-02-27

Decision Date 2023-02-28

Refile N

Original File Date -

Previous State Work Force Agency (SWA) Case Number Stete -

Schedule A or a Sheepherder Occupation N

Company Info

14 fields

Employer Name EDWARDS LIFESCIENCES LLC

Employer Address_Line 1 ONE EDWARDS WAY

Employer Address_Line 2 -

Employer City IRVINE

State -

Employer State/ Province CALIFORNIA

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 92614

Employer Phone No. (949) 250-6338

Employer Phone Extent No. -

Total Number of Employees 16000

Employer Year of Commenced 2000

NAICS Code 339112

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Diana Fernando

Employer Contact Address Line1 One Edwards Way

Employer Contact Address Line2 -

Employer Contact City Irvine

Employer Contact State/ Provice CALIFORNIA

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 92614

Employer Contact Phone (949) 250-2350

Employer Contact Email Diana_Fernando@edwards.com

Attorney

11 fields

Agent/ Attorney Name Diana V Coker

Agent/ Attorney Firm Name Larrabee Albi Coker LLP

Agent/ Attorney Phone (858) 642-0420

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 P.O. Box 919016

Agent/ Attorney Address Line 2 -

Agent/ Attorney City San Diego

Agent/ Attorney State/ Province CALIFORNIA

Agent/ Attorney Country UNITED STATES OF AMERICA

Agent/ Attorney Postal Code -

Agent/ Attorney Email Diana@larrabee.com

Position Info

89 fields

Prevailing Wage Track Number P10022138183196

Prevailing Wage SOC Code 27-3042.00

Prevailing Wage SOC Title Technical Writers

Prevailing Wage Skill Level Level IV

Prevailing Wage 103917

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2023-02-14

Prevailing Wage Expiration Date 2023-06-30

Wage Offer From 175000

Wage Offer To -

Wage Offer Unit of Pay Year

Workstie Address Line 1 100 telecommute position reporting to One Edwards Way

Worksite Address Line 2 -

Worksite City Irvine

Worksite State CALIFORNIA

Worksite Postal Code 92614

Job Title Manager, Medical Writing

Minimum Education Doctorate

Other Degree/ Diploma -

Major Field of Study Sciences (Pharmaceutical, Chemical) or a related field

Required Training N

Required Training Month -

Required Field of Training -

Required Experience N

Required Expreience Months -

Accept Alternate Field of Study Y

Accept Alternate Major See H.4B

Alternate Combination of Education/ Experience Y

Required Alternate Level of Education Master's

Other Alternate Level of Education -

Acceptable Years of Experience 6

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 36

Accept Alternate Job Title medical writing, clinical documents research or processing contd in H.14

Normal Requirements of Job Opportunity N

Required Foreign Language 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 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 2022-09-26

Job Oder End Date 2022-10-27

Sunday Edition Newspaper Y

First Newspaper Name Orange County Register

First Advertisement Start Date 2022-10-09

Second Newspaper Name Orange County Register

Second Advertisement Type Newspaper

Second Ad Start Date 2022-10-16

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 2022-10-10

Job Search Website to Date 2022-10-16

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date -

Employee Referral Program to Date -

Campus Placement from Date 2022-10-02

Campus Placement to Date 2022-10-10

Local Ethnic Newspaper from Date 2022-10-10

Local Ethnic Newspaper to Date 2022-10-10

Radio/TV Ad from Date -

Radio/TV Ad to Date -

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

24 fields

Foreign Worker Education Doctorate

Foreign Worker Education Other -

Foreign Worker Major PHARMACEUTICAL AND CHEMICAL SCIENCE

Year of Compelted Education 2017

Foreign Worker Istitution of Eduation UNIVERSITY OF THE PACIFIC

Foreign Worker Education Instution Address Line 1 3601 PACIFIC AVENUE

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City STOCKTON

Foreign Worker Educatution Institution State CA

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 95211

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N/A

Foreign Worker Alternate Education and Experience N

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 Diana V Coker

Preparer Title Partner Attorney at Law

Preparer Email Diana@larrabee.com

Employer Information Declaration Name Tracie M Pham

Employer Declaration Title Senior Talent Mobility Specialist