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Philips Senior Medical Writer United States, California, San Diego 139896759
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As the Senior Medical Writer, you willbe responsibletechnical documents that supportEuropean Unionand other internationalYou will alsomentor junior medical writers andMedical Affairs ining scientific communication documents such as maand podium presentations.
Your role:
- Author Clinical Investigation Plan (CIP) for all upcoming AM&D clinical trials
- Author Premarket Application (PMA),510k Premarket Submission,Clinical Study Report (CSR),Annual Progress Report (APR)
- Author Clinical Evaluation documents forexisting andnew products andmaintain/update existing companyClinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) Plans and PMCF Reportsaccording to MEDDEV 2.7.1, Rev. 4 and compliant to EU MDR
You're the right fit if:
- You have an MSDegree in scientific or medical discipline with at least6years of experience inthe medical device industryfocusing onclinical evaluation report writing orscientificwriting and/orPhD, MD, PharmD, or equivalent with at least4years of relatedexperience
- In depthexperience and skill performing systematic medical/ scientific literature searches (PubMed, Google Scholar, etc.),critically assessfindingsandresearchmethodologyexperience (including clinical investigation design and biostatistics)
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
- Excellent written and oral communications skills;
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .
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US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
be provided for this position. For this position, you must reside inwithin commuting distance to San Diego, CA
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