EDWARDS LIFESCIENCES LLC

Manager, Medical Writing

A-23011-85540 H-1B 2023 Withdrawn

Salaire

$103,917

Type de visa

H-1B

Intitulé du poste

Manager, Medical Writing

Citoyenneté de l'employé

INDIA

École de diplôme

UNIVERSITY OF THE PACIFIC

Info du cas Info entreprise Info RH Avocat Info poste Info employé

Info du cas

9 fields

数据公布年 2023

申请编号 A-23011-85540

申请状态 Withdrawn

收件日期 2023-02-27

通过日期 2023-02-28

曾备案（Y/N） N

原备案日期 -

原SWA申请编号 -

是否为紧缺/短缺职位 N

Info entreprise

14 fields

雇主公司名 EDWARDS LIFESCIENCES LLC

雇主地址-第一行 ONE EDWARDS WAY

雇主地址-第二行 -

雇主城市 IRVINE

申请州 -

雇主所在州/省 CALIFORNIA

雇主所在国 UNITED STATES OF AMERICA

雇主邮编 92614

雇主电话 (949) 250-6338

雇主分机号 -

雇员总数 16000

雇主经营年限 2000

北美行业代码 339112

雇员雇主所有权及家庭联系 N

Info RH

9 fields

雇主联系人 Diana Fernando

雇主联系人地址 One Edwards Way

雇主联系人地址 -

雇主联系人城市 Irvine

雇主联系人州/省 CALIFORNIA

雇主联系人国 UNITED STATES OF AMERICA

雇主联系人邮编 92614

雇主联系人电话 (949) 250-2350

雇主联系人邮件 Diana_Fernando@edwards.com

Avocat

11 fields

代理人/律师姓名 Diana V Coker

代理人/律师公司名称 Larrabee Albi Coker LLP

代理人/律师电话 (858) 642-0420

代理人/律师分机号 -

代理人/律师地址 P.O. Box 919016

代理人/律师地址 -

代理人/律师城市 San Diego

代理人/律师州/省 CALIFORNIA

代理人/律师国 UNITED STATES OF AMERICA

代理人/律师邮编 -

代理人/律师邮箱 Diana@larrabee.com

Info poste

89 fields

现行工资跟踪号 P10022138183196

职业代码 27-3042.00

职业名称 Technical Writers

技能等级 Level IV

现行工资 103917

现行工资周期 Year

现行工资信息实体 OES

其他现行工资信息来源 -

现行工资确定日期 2023-02-14

现行工资失效日期 2023-06-30

起薪点 175000

工资最高点 -

工资支付周期 Year

工作地址 100 telecommute position reporting to One Edwards Way

工作地址 -

工作城市 Irvine

工作州 CALIFORNIA

工作邮编 92614

工作职位 Manager, Medical Writing

最低学历 Doctorate

其他教育学历 -

对应专业 Sciences (Pharmaceutical, Chemical) or a related field

所需培训 N

培训时长 -

所需培训领域 -

前置经验 N

经验时长（月） -

替代领域学历 Y

替代专业 See H.4B

可替代教育及经验组合 Y

所需教育层级 Master's

其他可替代教育层级 -

认可经验年限 6

境外教育背景 Y

可替代职业 Y

可替代职业时长（月） 36

可替代职业名称 medical writing, clinical documents research or processing contd in H.14

是否为正常职业要求 N

是否需要外语 N

特殊技能 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.

职业组合 N

是否提供给申请人 Y

是否在地工作 N

是否为住家家政 N

是否签订合同 -

是否为专业职业 Y

是否为大学老师 N

竞争性招聘 -

基础招聘流程 -

竞争性招聘日期 -

广告投放期刊名 -

补充招聘信息 -

SWA订单开始日期 2022-09-26

SWA订单结束日期 2022-10-27

周日见报 Y

首次见报刊名 Orange County Register

首次见报日期 2022-10-09

二次见报刊名 Orange County Register

二次刊登种类 Newspaper

二次刊登日期 2022-10-16

招聘会起始日期 -

招聘会截止日期 -

校招起始日期 -

校招截止日期 -

雇主网站起始日期 -

雇主网站截止日期 -

专业机构起始日期 -

专业机构截止日期 -

招聘网站起始日期 2022-10-10

招聘网站截止日期 2022-10-16

私营就业起始日期 -

私营就业截止日期 -

内推起始日期 -

内推结束日期 -

校办推荐起始日期 2022-10-02

校办推荐截止日期 2022-10-10

本地报纸起始日期 2022-10-10

本地报纸截止日期 2022-10-10

电台/TV广告起始日期 -

电视/TV广告截止日期 -

聘方收费 N

收费细节 -

通知谈判代表 N/A

备案通知张贴 Y

雇主裁员 N

通知美国工人 -

外籍工人国籍 INDIA

工人出生国籍 INDIA

工人签证状态 H-1B

Info employé

24 fields

教育背景 Doctorate

其他教育背景 -

专业背景 PHARMACEUTICAL AND CHEMICAL SCIENCE

教育完成年份 2017

教育机构名 UNIVERSITY OF THE PACIFIC

教育机构地址1 3601 PACIFIC AVENUE

教育机构地址2 -

工人受教城市 STOCKTON

工人受教州 CA

工人受教国 UNITED STATES OF AMERICA

工人受教邮编 95211

是否完成培训 N/A

所需经验 N/A

教育和经验 N

外国工人经验 Y

雇主经验 N

雇主教育报销 N

受雇于请愿雇主 Y

雇主申请完成 N

准备者姓名 Diana V Coker

准备者职位 Partner Attorney at Law

准备者邮件 Diana@larrabee.com

雇主声明签字者姓名 Tracie M Pham

雇主声明签署者职位 Senior Talent Mobility Specialist