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.