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 stakeholders is 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 with 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 emails which are adapted to the needs of the 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.