Medical Advisor RWE Japan Analyst/Non-Line Manager/Medicine Management

Basic purpose of the job . Develop and implement real world evidence strategy in Japan, support non-interventional (observational) studies, develop and improve interactions with key internal and external stakeholders, including authority and external experts. .

Contribute to strategic RWE generation by identifying optimal data sources and providing scientific expertise to evidence planning and execution Accountabilities Develop, execute, and report non-interventional (observational) studies, including: - Post-approval commitments from PMDA that use real world evidence (RWE) - Disease epidemiology and patient population characterization for development and marketed products, including disease incidence and prevalence, assessment of current treatment patterns, drug utilization, subgroup profiles, and unmet need - Comparative studies of the real-world safety, effectiveness, healthcare resource utilization, and cost for BI products compared to competitors - Regional studies of our products using data sources from across Asia Related performance indicators Deliver study results per required time-line Deliver real world evidence strategy as requested Contribute to the real- world evidence strategy for assigned products and projects, in cooperation with local and global colleagues Provide epidemiological and statistical guidance to observational research within BI, acting as a subject matter expert (SME) in study design, analysis, and interpretation Provide professional advice in a timely manner Provide critical review and input on: - Non-interventional (observational) study proposals - Publications (internal or from the medical literature) - Expert statements and 'white papers' - Data sources for RWE studies in Japan and throughout Asia - Other epidemiology or RWE-related documents High-quality critical reviews Review, assess, and summarize medical literature (in English and Japanese) to support study development, regulatory responses, and internal decision making; Contribute to relevant sections of regulatory documents (e.g. Risk Management Plans, NDAs) Deliver high-quality literature review and document sections on time Work with colleagues to develop an expert network in Japan to support real world evidence study activities and collaborations Establishment and maintenance of an epi expert network in Japan Identify and evaluate internal and external real-world data (RWD) sources aligned with NBI evidence strategy, including feasibility assessment and data landscaping Generate high-quality regional evidence Identify, assess, and manage external analytics vendors to ensure high-quality, timely, and fit-for-purpose study delivery Delivery of high-quality, timely, and fit-for-purpose vendor outputs in compliance with study requirements and agreed timelines Regulatory and / or Organisational Requirements · PMDA PMS requirements Job Complexity .

The changing regulatory environment in Japan as well as in Asia region . Data sources in Japan and the Asia region are still under development, studies based on these data sources are facing methodological challenges · Awareness of real world evidence among in- and external stakeholder:s still being established Interfaces .

Interaction with authorities in Japan as well as in Asia region · Partnership with external partners on observational studies and network building . Collaboration with multiple internal stakeholders to develop and implement real world evidence strategy Job Expertise .

Familiar with regulatory process and requirements in Japan, experience with regulatory interaction · Understanding of data sources in Japan and in Asia region · Business insights Job Impact . Interaction with authority and support for PMS to make sure 1) BI is compliant to PMDA requirement; and 2) the PMS is scientifically sound .

Generate RWE to support BI product Minimum Education/Degree Requirements · Graduate degree (preferable and highly desirable: PhD) from an accredited institution and/ or post-graduate training in applied analytic disciplines, such as epidemiology, health outcomes, health informatics, biostatistics or health economics . Master's with 10 years of experience in the analysis of RWD OR PhD with 6 years of experience in the analysis of RWD Required Capabilities (Skills, Experience, Competencies) .

Senior level of expertise in the analysis of RWD . 5+ years of industry experience is also preferred (pharma/CRO) · Working experience in R · Mandatory experience working with large healthcare databases · Advanced knowledge of epidemiologic methods and/or health economics, such as propensity score analysis and marginal structural modeling · Experience in working with and managing external data or analytics vendors (e.g., CROs, database providers) . Ability to communicate effectively in English, including the ability to produce documents and e-mails which are adapted to the needs of audience. · Strong organizational, time-management and prioritization skills necessary to evaluate, plan and accomplish multiple work goals in a timely fashion. · Required English speaking CEFR level : B2