Medical Writer

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.