Purpose Leads and executes specific observational research projects within a product team or therapeutic area Contribute to observational research throughout the product commercialization process Responsible for : Conducting research to the highest standards of the profession Aligning research with the product team’s medical strategies Participating in initiatives to improve processes / capabilities in evidence generation activities Key Activities and Skills Conduct of our-
sponsored observational studies : Develops study proposals and protocols in high quality Conducts high-quality observational research to support medical strategy Develops scientific manuscripts and presentations for a variety of audiences Supports post-
marketing surveillance using existing databases Addresses regulatory and compliance requirements related to observational research Manages vendors with controlling contract, budget, and timeline Coordinates data purchase agreements Facilitation of observational research and use of real-
world evidence : Contributes to medical strategy with observational research expertise Contributes to real-world data analyses to support various business needs Establishes processes for local observational research operations as needed Collaborates with relevant internal / external stakeholders Sets annual product-
specific and personal goals Takes leadership in a matrix environment Promotes observational research awareness Stays abreast of the latest developments in the field of observational research and drug development to contributes to the field
世界最大級の独立バイオテクノロジー企業と 内資系研究開発型グローバル製薬企業との合弁会社高脂血症治療薬 骨粗鬆症治療薬 抗がん剤領域等合計6つの開発品目について日本における開発及び商業化を行っております
Basic Qualifications Masters degree in Epidemiology or other subject with high observational research content or MD with observational research experience Five (5) or more years of clinical research and / or observational research experience in industry or academic settings Record of publications in clinical and / or observational research Preferred Qualifications Doctorate in Epidemiology or other subject with high observational research content Experience in research to support drug development and / or pharmacovigilance in industry Required Knowledge Observational research methodology and applications Programming in SAS or other software (e.
g. STATA) Literature search Drug development processes and operations Relevant regulations and guidelines Written and oral scientific communications skills Project management / project planning Native level Japanese and Business English (oral and written)