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
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: