Clinical Development Scientist
1 maand geleden
As Clinical Development Scientist you will develop the clinical evidence strategy, execution and dissemination in support of assigned DXR (Diagnostic X-Ray) programs. You will provide input to the cross-functional team through strong critical scientific thinking to develop innovative solutions for evidence strategy development.
Your role:
Leading development of evidence generation strategies of assigned projects, working within a cross-functional team.
Creating subsequent clinical development / evaluation plans.
Developing strong collaboration with KOLs (Key Opion Leaders) and Investigators.
Participate in the interpretation & dissemination of evidence generated from clinical evaluation plans such as Clinical Study Reports and Clinical Evaluation Reports.
Supporting clinical evidence discussions with regulators, advisory boards, associations and societies.
You're the right fit if you have:
MD, PhD / MS Degree in Science, or bachelor’s degree with equivalent experience.
3-5 years of years’ experience in clinical research / development function.
Proven medical writing skills for EU MDR clinical evaluation documentationwith a strong ability to critically assess clinical literature.
Experience transition from MDD (Medical Device Directive) to MDR (Medical Device Regulations).
We are open for people with a pharma/IVD/biotechnology medical writing experience background.
Strong scientific background and deep expertise in the development of clinical evaluation methods.
Deep knowledge and understanding of all applicable standards / regulations in clinical evidence generation and dissemination, including GCP, FDA requirements, EU MDR, NMPA (National Medical Products Administration), etc., and a broad understanding of the clinical operations required to execute evidence generation strategies.
Experience communicating with notified bodies is a preference.
Excellent communication skills, including written communication (e.g., peer review publication) and oral presentation of scientific materials and research results. About Philips 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 the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.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 here.
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