Clinical Scientist

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care. The Clinical Scientist will develop and author Clinical Evaluation Plans and Clinical Evaluation Reports, support regulatory submissions and responses for CE Mark applications, and maintain EU product conformance. The role also involves literature analysis, clinical evidence development, cross-functional collaboration, and support for clinical affairs activities.

Responsibilities

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., SOPs) and regulatory requirements (e.g., GCP and US and OUS guidelines)

Preferred

Minimum of 0-2 years of experience in Clinical Evaluation Report (CER) writing in a medical device industry is preferred

Minimum of 0-2 years of experience in Clinical Evaluation Report (CER) writing in a medical device industry is preferred.

Medical device industry experience

Benefits

Remote work arrangement; employees will come onsite when requested by the leader.

Company

Robotic-assisted surgical systems for minimally invasive care.

Sunnyvale, California, USA

https://www.intuitive.com/

Founded in 1995

10001+ employees

Qualifications

Previous experience in the application of in-depth therapeutic and device knowledge to the development of Clinical Evaluation Plans and Reports

Minimum of 2 years of medical writing experience

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

Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills

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

Minimum of 0-2 years of experience in Clinical Evaluation Report (CER) writing in a medical device industry is preferred

Minimum of 2 years of medical writing experience.

Required skills

Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Medical Writing, Clinical Literature Search and Appraisal, Clinical Trial Data Analysis, Clinical Protocol Development, Regulatory Submission Writing, EU MDR, Clinical Practice (GCP)

Experience

2+ years