Primary Function of Position
This position reports to the Sr. Manager, Medical Sciences, and requires a candidate with a strong interest in medical writing of clinical and regulatory documents. This position will focus on medical literature review, clinical data summary, and the development of certain sections of Clinical Evaluation Reports in support of the EU CE Mark application. This role may also support the clinical review of US marketing materials.
Essential Job Duties
This position has responsibility and authority for the following:
- Review and contribute to authoring clinical documentation, mainly the Clinical Evaluation Reports (CER), including the clinical section of other regulatory documents.
- Learn about therapeutic areas.
- Contribute to the critical review of clinical content in promotional material.
- May assist with the development of clinical literature reports or other clinical documents such as protocols, clinical study reports, conference abstracts, and peer-reviewed publications.
- Have a basic understanding of the literature review processes.
- Participates in and/or performs comprehensive literature searches to develop knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies.
- Work with the clinical librarian to help with conducting literature searches on products/product families.
- 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.
- Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
Required Skills and Experience
University Hiring Program Eligibility Requirements:
- University Enrollment: Must be currently enrolled in and returning to an accredited degree-seeking academic program after the internship.
- Internship Work Period: Must be available to work full-time (approximately 40 hours per week) during a 10-12 week period starting May or June. Specific start dates are shared during the recruiting process.
Required Education and Training
- Current enrollment in a scientific field degree-seeking program at the Master’s, MD or Doctorate level.
Working Conditions
- None
Preferred Skills and Experience
- Some experience in an academic environment conducting literature searches, reviews 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 and analytical thinking skills.
- Must have a high level of attention to detail and accuracy.
- Must be able to work effectively across cross-functional teams.
- Strong presentation and interpersonal skills.
- Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude)
- Consistently shows dedication or strong work ethic to help meet aggressive timelines or multiple projects when necessary
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Accommodation & Accessibility Notice:
Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at HRHelpNow@intusurg.com.
We provide market-competitive compensation packages, inclusive of base pay (paid at an hourly rate), benefits, and a housing allowance. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including relevant skills and experience for this internship, degree-seeking academic program (PhD, Master’s, Bachelor’s, etc), year in school, and location. The hourly rate is prorated against the intern program salaries listed and total program compensation will be based on internship duration.