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Intuitive

A global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery.

Senior Clinical Scientist

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 5,001-10,000Since 1995H1B SponsorCompany SiteLinkedIn

Location

California

Posted

35 days ago

Salary

$150.1K - $216.1K / year

Seniority

Senior

Postgraduate Degree5 yrs expEnglish

Job Description

Senior Clinical Scientist

Intuitive

• This position reports to Manager/Sr. Manager, Medical Sciences and requires expertise in the analysis of medical literature, data from clinical trials and pre-clinical studies • The position mainly focuses on the development of Clinical Evaluation Plans (CEPs) & Clinical Evaluation Reports (CERs) • Develop and author clinical documentation for regulatory submissions, mainly key sections of the CEP, and the entire CER document • Develop and author responses to requests and questions on the clinical documentation from the regulatory authority • 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 • Review scientific literature and interpret and summarize published data on risks, alternate therapies and device-specific benefits • Manage CEP/CER timelines required by product development teams and global Regulatory Bodies by utilizing appropriate project management tools

Job 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.

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible work arrangements
  • Professional development opportunities

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