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

RWE Japan

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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

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