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Johnson & Johnson MedTech focus on Vision is recruiting for a Principal Clinical Research Scientist, to be located in Milpitas or Irvine, CA, or in Jacksonville, FL.
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Position summary
The Principal Clinical Research Scientist for the Surgical Vision platform is an expert in ophthalmic and medical device research who is a core team member on key projects. Your insights will drive the strategic direction for crafting clinical programs that generate scientific evidence to bring new technologies to eye care professionals and their patients.
You should have an in-depth understanding of clinical research (science and execution), as well as familiarity with new product development, design control, and ophthalmic device regulations. A good grasp of related healthcare markets and clinical trends is also beneficial. You demonstrate a consistent track record as a key leader and contributor in complex projects, who delivers as promised. Be able to independently build collaborative relationships, influence and align with your functional partners, prioritize multiple projects, and delegate when efficient.
Essential Responsibilities
Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs.
Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle
Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.).
Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections
Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies
Performs other related duties as assigned by management.
