Jonas Carlo Viola Email & Phone Number

London, England, United Kingdom

• Plans and executes general medical writing activities and systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER) for assigned therapeutic area and projects within the client’s.
• Interprets and summarizes complex results from the medical and scientific literature and present them in clear, concise, and scientifically accurate manner to various end users requiring the ability understand and.
• Works closely with other Medical Operation Team members including Medical Directors, and Project Managers to interpret clinical data from medical and scientific literature during the screening and data extraction steps.
• Collaborates with other Medical Operation Team members including Technical Specialists and Project Managers as applicable to gather information (timelines, projects, documents)
• Communicates with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER process to identify the necessary.
• Demonstrates an understanding in assigned therapeutic areas, provides expertise in device technology, interprets clinical research methodology and study design, ensures compliance with medical device regulations.

• Plans and executes general medical writing activities and systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER) for assigned therapeutic area and projects within the client’s.
• Prepares, writes, and edits creditable systematic literature reviews through the creation of protocols and reports in order to synthesize and analyze the clinical data from medical and scientific publications reporting.
• Participates in core process steps for systematic literature reviews including search, screen, data extraction, analysis, and synthesis of the literature for CER processes
• Performs data extraction of included studies into a data collection tool (e.g. Microsoft Excel, Distiller).
• Utilizes software to support the core process steps for systematic literature reviews including statistical analysis tools (e.g. Distiller, QUOSA, SAS)
• Extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports.

• Reviews adverse event data and authors aggregate safety reports for consumer products to ensure compliance with company standards and regulatory reporting requirements worldwide
• Evaluate literature and conduct systematic reviews of available medical and safety data, and other appropriate sources for inclusion into the aggregate reports
• Participation in quality and compliance audits and inspections

• Performs primary review of cases upon case receipt; performing data entry, coding of events, medical conditions, concomitant medications, and safety information into client database in accordance with guidelines and.
• Performs seriousness assessment, prioritization of cases, and quality review to validate adverse event case information against source documents as applicable (Clinical trials, spontaneous adverse event reports.
• Performs PV quality checks on completed cases, validates accuracy of documentation, and provide quality feedback/peer review to colleagues as applicable
• Performs Medical writing activities specified by effective SOP, work instructions, and timelines on the assigned project
• Proactive communication with internal (peers) and external (client) members of the team to achieve stipulated productivity and quality targets
• Coordination with internal and external team members to obtain necessary information required for day-to-day operations