In this role, you will review, analyze, and summarize scientific literature and clinical data to generate clinical evidence documentation for compliance with the European Regulation on in vitro diagnostic medical devices (IVDR). Drafts sections for package inserts and other labeling documents. Reviews and contributes to clinical performance evaluation plans and reports, package inserts, other labeling, and clinical information in technical files and health authority (HA) submissions. Stays informed of performance evaluation requirements published or communicated by major HAs.
Actively participates in implementation of strategy to address IVDR clinical evidence requirements across the product portfolio.
Conducts scientific literature reviews, objectively evaluates data, and prepares documentation (eg, scientific validity reports and clinical performance reports) for in vitro diagnostic products.
Demonstrates understanding of intended uses of IVDs and their application in clinical practice and applies this understanding to critical review of data and preparation of reports.
Ensures high quality documentation with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines.
Works with a cross-functional team (eg, Regulatory Affairs, Development, Medical Office, Quality, Marketing) to ensure timely completion and approval of clinical evidence documentation for Technical Files.
Interfaces with Regulatory Affairs and other groups and other units to stay informed about current performance evaluation requirements published or communicated by major HAs; including but not limited to IVDR guidance documents and implementing acts.
Miscellaneous duties and special projects as assigned, including deliverable tracking, process improvement, and literature review-based reports to support product registrations and marketing applications.
Tracks progress of assigned deliverables to ensure timelines and other project team needs are met.
Serves as a functional area subject matter expert for document management.
Minimum of 2 years’ experience in study design, data interpretation, and report writing for clinical or non-clinical studies.
Experience writing reports for regulatory submissions and marketing applications is a plus.
Experience in the IVD device industry, and/or immunohistochemistry, histology, cancer biology/oncology is desirable.
Knowledge, Skills, and Abilities:
Application of scientific principles and concepts
Literature databases and search methods
Statistical basis for diagnostic device performance characteristics
Biomarker characterization, diagnostic testing laboratory workflow, histology, immunohistochemistry, and molecular biology
Excellent verbal, written, and presentation communication skills;
Proficiency with software programs used to prepare documents (Microsoft Word, Adobe Acrobat Professional, EndNote);
Outstanding organizational skills.
Produce quality reports independently;
Drive progress on multiple projects simultaneously;
Prioritize work and meet timeline;
Follow processes and operate within a fast-pace environment;
Develop product and related disease area medical and scientific knowledge;
Develop expertise in the company’s internal document management system;
Be passionate about improving the lives of all patients afflicted with cancer.
Source: Job Diva – Job Listing