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