Company DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Primary Function of Position:
The Clinical Literature Specialist is principally responsible for medical writing needs for Clinical Affairs EMEA. This includes literature searches, analyses, reviews, compilation and summarization and collaboration with researchers. Literature management responsibilities include tracking external and internal information sources and searches for trial information or evidence from other relevant information sources eg e-media. The role also supports organizational and contribution to development and use of clinical claims and proactively develops means to inform the organization of new developments effectively influencing strategies.
The Clinical Literature Specialist independently reviews and determines clinical approval of advertisement and promotional material in alignment with internal processes, other functions and in line with regulatory regulations. This role reports to the Sr/Manager, Clinical Affairs Information and may be home based in Europe or at any European Intuitive office.
Roles and Responsibilities:
- Understand Clinical Affairs research priorities and develop literature search strategies and reports based on them.
- Monitors relevant information from a wide range of sources, e.g. SCOPUS, Pubmed, Clintrials.gov, Twitter, society websites, society/country practice guidelines, national government research guidance websites, and internal sources of information, for research projects, publications and scientific statements...
- Performs expert literature searches using advanced search tools/methods.
- Critically appraises publications/evidence relevant for intuitive and creates summaries for use by various stakeholders.
- Supports the development of clinical claims.
- May support Clinical evidence report (CER) development.
- Maintains an up to date evidence portfolio for use by stakeholders, in line with their needs, training stakeholders on its use.
- Creates publication reviews and summaries for internal and external presentation e.g. for new studies or analysis of new potential studies, and supports development of collateral materials
- Supports the clinical affairs newsletter and homepage (intranet) with scientific content.
- Creation and maintenance of relevant quality system processes (DOP, WI and forms).
- Supports clinical affairs team with medical writing e.g. protocols and research strategies.
- Develops custom reports on specific areas of research interest for internal and external use.
- Provides clinical affairs guidance in partnership with regulatory affairs, legal public relations marketing, Government Affairs, and other parties during the development of advertising and promotional materials including development of claims matrices for surgical procedures and products.
- Independently reviews and approves proposed advertising and promotional materials for conformance to applicable Intuitive processes, known applicable medical device regulations and available clinical evidence ensuring appropriate support for materials.
- Supports the development of new claims for EMEA and territories supported by this clinical affairs group.
- Analysis of existing literature as a service to customer requests and provision of references.
- Guidance on publication e.g. target journals, formats, styles.
Required Knowledge, Skills, and Experience:
- Experience in clinical research, medicine or science degree, or librarian (healthcare).
- Expertise in scientific documentation and analysis.
- Minimum 3-5 years’ experience in a comparable role.
- Experience in medical device (preferred) / pharma industry environment.
- Fluent in English (must) and German and French (at least one of these, ideally both).
- Significant knowledge of clinical studies and study design, outcomes research and critical review of literature is necessary Expertise in research and scholarly publication resources and process methodologies.
- Familiarity with literature sources, extraction, compilation and management tools.
- High level of organizational skills, communication /presentation style.
- Ability to monitor large amounts of information from different channels and select material of importance.
- Ability to produce high quality results under time pressure.
- Excellent communication skills.
- Ability to learn quickly and self-educate on different surgical specialties (Self-starter attitude).
- Ability to work with multiple teams on multiple projects simultaneously.
- Strong reading comprehension, critical thinking skills, detail orientation.
- Proficient in MS Office (Excel, PowerPoint, Word, etc.) and other evidence management tools
- Understanding of statistics and statistical methods commonly used in peer reviewed articles.
- Experience in medical writing such as preparing protocols for clinical research or dissemination of scientific publications/evidence for different audiences e.g. physicians, sales, public.
- Knowledge of evidence-based medicine practices and tenets.
- Medical knowledge as pertaining to medical devices for surgery.
- Experience with reference management software (Endnote, Mendeley, etc.).
- Experience in the review of marketing materials or other collateral materials.
- Experience in conducting Systematic review, value dossiers or Clinical evidence reports (CER) preferred.
Intuitive is an Equal Employment 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.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Travel: 25% of the time