Job Information
Boehringer Ingelheim Medical Advisor EPI Analytics Lead/スタッフ or ノンラインマネージャー/ 医薬開発本部エピデミオロジージャパン in Shinagawa, Japan
Basic purpose of the job
Develop and implement real world evidence strategy in Japan and Asia region, support おobservational non-interventional studies, develop and improve interactions with key internal and external stakeholders, including authority and external experts.
Accountabilities
Develop, execute, and report observational non-interventional 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 BOEHRINGER INGELHEIM 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
Contribute to the real world evidence strategy for assigned products and projects, in cooperation with local and global colleagues
Related performance indicators
Deliver real world evidence strategy as requested
Provide real world evidence and epidemiology advice to various in- and external stakeholders
Related performance indicators
Provide professional advice in a timely manner
Provide critical review and input on:
Observational Non-interventional 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
Related performance indicators
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.q. Risk Management Plans, NDAs)
Related performance indicators
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
Related performance indicators
Establishment and maintenance of an epi
expert network in Japan
Develop and integrate regional evidence from Asia to provide support for BOEHRINGER INGELHEIM products
Related performance indicators
Generate high-quality regional evidence
Clearly communicate about the RWE/Epi group and RWE studies to various internal and external stakeholders, including multifunctional product teams, local and global management, regulators, scientific and medical
societies, and others
Related performance indicators
Develop and implement communication plan
Regulatory and I or Organizational Requirements
- PMDS 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 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) BOEHRINGER INGELHEIM is compliant to PMDA requirement; and 2) the PMS is scientifically sound
Generate RWE to supportBOEHRINGER INGELHEIM 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 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
·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
Recruiter : Suzuki
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.