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Senior Clinical Scientist
IntuitiveSenior Clinical Scientist role focused on developing Clinical Evaluation Plans and Reports. Working for a leader in robotic-assisted surgery and minimally invasive care.
Posted 7/9/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $150,100 - $216,100 per yearWebsite
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- This position reports to Manger/Sr. Manager, Medical Sciences and requires a strong candidate with expertise in the analysis of medical literature, data from clinical trials and pre-clinical studies, and sound knowledge of applicable regulations and standards.
- The position will mainly focus on the development of Clinical Evaluation Plans (CEPs) & Clinical Evaluation Reports (CERs), with a potential for future additional responsibility in the development of other clinical evidence documents.
- The purpose of this job is to work collaboratively to develop strategies for the creation of CEPs followed by the development of clinical evaluation reports (CERs) per EU MDR, to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, re-certification and proposed indication/labeling changes.
- Further, the responsibility includes the development of regular CEP and CER updates to maintain EU product conformance.
- Interact with internal cross-functional teams (engineering, product development, regulatory, post-market surveillance) to define and plan the strategy for the development of CEPs and CERs for new products requiring CE Mark.
- Develop and author clinical documentation for regulatory submissions, mainly key sections of the CEP, and the entire CER document.
- Develop and author responses to the requests and questions on the clinical documentation from the regulatory authority.
- Possess or acquire in-depth knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
- Participate in and/or perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies; stay informed about applicable clinical landscapes and trends.
- Provide product guidance and expertise to the clinical librarian to facilitate conducting literature searches on products/product families.
- Review scientific literature and interpret and summarize published data on risks, alternate therapies and device-specific benefits; collect and summarize primary data to support risk assessment.
- Critically appraise scientific literature and write clinical summaries for products and surgical procedures.
- Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.
- Manage CEP/CER timelines required by product development teams and global Regulatory Bodies by utilizing appropriate project management tools.
- Serve as the SME and/or functional representative for R&D development activities (e.g., Product or Technology Development Process teams) and support broader Clinical/Medical Affairs activities such as Regulatory submissions/responses.
- Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented.
- Provide clinical perspective and support and guide new product development for CE Mark purposes.
- May require participation in ongoing core team activities (e.g., weekly meetings) or provide periodic participation and input as needed.
- Support the clinical affairs (CA) team with the creation of clinical content for other documents including Investigator brochures, manuscripts, scientific abstracts, conference presentations, and posters based on Intuitive clinical trials.
- Support the CA team with the development and writing of clinical study protocols and Clinical Study Reports (CSRs).
- Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
Requirements
What you’ll need- Previous experience in the application of in-depth therapeutic and device knowledge for the development of clinical evaluation plans and reports
- Ability to identify critical information needs and identify roles / individuals to involve in the decision-making process within clinical evaluation assessment and report development
- Strong experience in conducting literature searches, and review and appraisal of scientific data.
- Expertise in clear and effective oral and written communication and in technical or scientific writing
- A minimum of 5 -8 years of medical writing experience
- Excellent critical thinking and analytical skills
- A high level of attention to detail and accuracy
- Ability to work effectively with cross-functional teams
- Ability to manage multiple projects across numerous surgical disciplines
- Strong communication, presentation and interpersonal skills with high attention to detail and organization
- Strong experience in protocol development, writing clinical sections of documents for regulatory submission and clinical evaluation report writing
- Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude)
- Consistent dedication and strong work-ethics to meet aggressive timelines and simultaneous management of multiple projects, when necessary
- MD, PhD or M.S. degree in a scientific field
Benefits
Comp & perks- 🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Intuitive Website LinkedIn All Job Openings 5001 - 10000 employees Founded 1995 ⚕️ Healthcare Insurance Healthcare Insurance
- Medical Devices Intuitive is a company known for its innovative surgical technologies, including the da Vinci Surgical Systems which are used for minimally invasive procedures. With three decades of demonstrated performance, Intuitive focuses on advancing healthcare by providing structured and measurable technology training pathways for surgeons, physicians, and OR care teams. Their vision is to improve patient outcomes through less invasive surgical care. Intuitive also offers a visual media platform for collaboration and learning, known as the Da Vinci Hub, and the Simnow platform for surgical training. The company is involved in ongoing innovation to explore new possibilities in surgical care. Senior Clinical Scientist Job not on LinkedIn 🔥 11 minutes ago 🏄 California – Remote 💵 $150.1k - $216.1k / year ⏰ Full Time 🟠 Senior 🧪 Clinical Research 🦅 H1B Visa Sponsor Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
- This position reports to Manger/Sr. Manager, Medical Sciences and requires a strong candidate with expertise in the analysis of medical literature, data from clinical trials and pre-clinical studies, and sound knowledge of applicable regulations and standards.
- The position will mainly focus on the development of Clinical Evaluation Plans (CEPs) & Clinical Evaluation Reports (CERs), with a potential for future additional responsibility in the development of other clinical evidence documents.
- The purpose of this job is to work collaboratively to develop strategies for the creation of CEPs followed by the development of clinical evaluation reports (CERs) per EU MDR, to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, re-certification and proposed indication/labeling changes.
- Further, the responsibility includes the development of regular CEP and CER updates to maintain EU product conformance.
- Interact with internal cross-functional teams (engineering, product development, regulatory, post-market surveillance) to define and plan the strategy for the development of CEPs and CERs for new products requiring CE Mark.
- Develop and author clinical documentation for regulatory submissions, mainly key sections of the CEP, and the entire CER document.
- Develop and author responses to the requests and questions on the clinical documentation from the regulatory authority.
- Possess or acquire in-depth knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
- Participate in and/or perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies; stay informed about applicable clinical landscapes and trends.
- Provide product guidance and expertise to the clinical librarian to facilitate conducting literature searches on products/product families.
- Review scientific literature and interpret and summarize published data on risks, alternate therapies and device-specific benefits; collect and summarize primary data to support risk assessment.
- Critically appraise scientific literature and write clinical summaries for products and surgical procedures.
- Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.
- Manage CEP/CER timelines required by product development teams and global Regulatory Bodies by utilizing appropriate project management tools.
- Serve as the SME and/or functional representative for R&D development activities (e.g., Product or Technology Development Process teams) and support broader Clinical/Medical Affairs activities such as Regulatory submissions/responses.
- Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented.
- Provide clinical perspective and support and guide new product development for CE Mark purposes.
- May require participation in ongoing core team activities (e.g., weekly meetings) or provide periodic participation and input as needed.
- Support the clinical affairs (CA) team with the creation of clinical content for other documents including Investigator brochures, manuscripts, scientific abstracts, conference presentations, and posters based on Intuitive clinical trials.
- Support the CA team with the development and writing of clinical study protocols and Clinical Study Reports (CSRs).
- Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines) 🎯 Requirements
- Previous experience in the application of in-depth therapeutic and device knowledge for the development of clinical evaluation plans and reports
- Ability to identify critical information needs and identify roles / individuals to involve in the decision-making process within clinical evaluation assessment and report development
- Strong experience in conducting literature searches, and review and appraisal of scientific data.
- Expertise in clear and effective oral and written communication and in technical or scientific writing
- A minimum of 5 -8 years of medical writing experience
- Excellent critical thinking and analytical skills
- A high level of attention to detail and accuracy
- Ability to work effectively with cross-functional teams
- Ability to manage multiple projects across numerous surgical disciplines
- Strong communication, presentation and interpersonal skills with high attention to detail and organization
- Strong experience in protocol development, writing clinical sections of documents for regulatory submission and clinical evaluation report writing
- Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude)
- Consistent dedication and strong work-ethics to meet aggressive timelines and simultaneous management of multiple projects, when necessary
- MD, PhD or M.S. degree in a scientific field Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Senior Manager, Global Strategic Feasibility 🔥 5 hours ago BeOne Medicines 10,000+ employees Website LinkedIn All Job Openings Senior Manager for Global Strategic Feasibility at BeOne, focusing on data-driven study planning and operational feasibility in oncology. Collaborating with global teams to accelerate clinical development processes. 🇺🇸 United States – Remote 💵 $136.4k - $181.4k / year ⏰ Full Time 🟠 Senior 🧪 Clinical Research Senior Clinical Trial Manager, Cardiac Catheter Products 🕒 Yesterday Pulse Biosciences, Inc. 51 - 200 🧬 Biotechnology Website LinkedIn All Job Openings Sr. Clinical Trial Manager managing global clinical trials for Catheter Ablation projects at Pulse Biosciences. Collaborating with teams to ensure data quality and compliance in a fast-paced environment. 🇺🇸 United States – Remote ⏰ Full Time 🟠 Senior 🧪 Clinical Research Global Feasibility Lead, Senior Manager 🕒 Yesterday Amgen 10,000+ employees 🧬 Biotechnology 💊 Pharmaceuticals 🔬 Science Website LinkedIn All Job Openings Global Feasibility Lead managing the feasibility strategy and country selection for clinical studies at Amgen. Leading a team to ensure high-quality execution and data-driven decision making. 🇺🇸 United States – Remote 💵 $138.7k - $187.6k / year 💰 $28.5G Post-IPO Debt on 2022-12 ⏰ Full Time 🟠 Senior 🧪 Clinical Research 🦅 H1B Visa Sponsor Clinical Research Scientist 🕒 Yesterday InStride Health 51 - 200 ⚕️ Healthcare Insurance 🧘 Wellness Website LinkedIn All Job Openings Clinical Research Scientist advancing quality and clinical effectiveness in pediatric mental health care through data-driven evaluation and research initiatives. Collaborating across teams to monitor care delivery and support decision-making. 🇺🇸 United States – Remote 💵 $106k - $118k / year 💰 $26M Venture Round on 2022-10 ⏰ Full Time 🟡 Mid-level 🟠 Senior 🧪 Clinical Research Senior Clinical Research Counsel 🕒 2 days ago ImmunityBio, Inc. 501 - 1000 🧬 Biotechnology ⚕️ Healthcare Insurance 💊 Pharmaceuticals Website LinkedIn All Job Openings Senior Clinical Research Counsel managing a wide range of contracts for clinical trials at ImmunityBio. Drafting, reviewing, and negotiating clinical trial agreements and ensuring compliance with regulations. 🇺🇸 United States – Remote 💵 $200k - $220k / year ⏰ Full Time 🟠 Senior 🧪 Clinical Research View More Clinical Researcher Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs
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Hard Skills & Tools
Clinical Evaluation PlansClinical Evaluation ReportsLiterature SearchesScientific WritingProtocol DevelopmentRegulatory SubmissionsData AnalysisRisk AssessmentDocument FormattingProject Management
Soft Skills
Attention to DetailCritical ThinkingInterpersonal SkillsCommunication SkillsOrganizational Skills
Certifications
MDPhDM.S. Degree in Scientific Field