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