Clinical Literature Specialist (Brussels)
Offre d'emploi mise en ligne le 15/09/2020
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
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 decides independently on the approval of advertisement and promotional material in alignment with other functions and with regulatory regulation and processes. This role reports to Clinical Affairs Manager EMEA and may be home based in Europe or at any European Intuitive office.
Roles and Responsibilities:
All clinical affairs
- Understand Clinical Affairs research priorities and develop search strategies based on them.
- Monitors sources for research projects, publications and scientific statements.
- Monitoring of relevant information from wide ranging sources, e.g. SCOPUS, Pubmed, clinicaltrials.gov, Twitter, society websites, society/country practice guidelines, national government research guidance websites, and internal sources of information.
- Perform expert literature searches using advanced search tools/methods.
- Independent custom report synthesis and generation, including data extraction, collection, summary, and organization.
- Reporting and critical appraisal of publications impacting the markets.
- Support the development of clinical claims.
- Maintenance of evidence portfolio.
- Support the clinical affairs newsletter and homepage (intranet) with scientific content.
- Create publication reviews and summaries for internal and external presentation e.g. for new studies or analysis of new potential studies, support development of collateral materials and strategies.
- Creation and maintenance of quality system processes (DOP, WI and forms).
- Project manager
- Support clinical affairs team with medical writing e.g. protocols and research strategies.
- Develop custom reports on specific areas of research interest.
- Other teams in EMEIA
- Provides clinical affairs guidance in partnership with regulatory affairs, legal public relations marketing 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.
- Customers support
- Analysis of existing literature as a service to customer requests and provision of references.
- Guidance on publication e.g. formats, styles.
Required Knowledge, Skills, and Experience:
- Must haves
- 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.
- 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.
- Additional skills
- Proficient in MS Office (Excel, PowerPoint, Word, etc.).
- Experience in medical device / pharma industry environment.
- 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.