メディカルアドバイザー (心不全・CKD領域)
700~1200万
日本ベーリンガーインゲルハイム株式会社
東京都品川区
700~1200万
日本ベーリンガーインゲルハイム株式会社
東京都品川区
医薬品メディカルアフェアーズ
Basic purpose of the job To contribute to execute CDMA (Clinical Development & Medical Affairs) activities in Japan according to TA (Therapeutic Area) strategy between start of preclinical development and late stages of commercialization. Accountabilities ・Strengthen Nippon Boehringer Ingelheim products’ profile by providing medical/scientific robust guidance in the responsible therapeutic area through the total process of the clinical development phases, in collaboration with Boehringer Ingelheim corporate and other department. ・Ensure and support Japanese submission and registrations in the respective products collaborating with regulatory/ clinical development team. (Support the clinical part until approval, such as preparation of responses to PMDA queries.) ・Responsible for making Japanese clinical development plan recognized by Boehringer Ingelheim global medicine as well aligned with global development strategy in the respective therapeutic area ・Support Nippon Boehringer Ingelheim make development/data building decision based on total picture (all projects/trials in the respects of resource/budget) in the therapeutic area ・Contribution to CDPs (Clinical Data Packages) after proof of concept and late stages of commercialization. ・Prepare Integrated Asset Plan & Detailed Annual Communication Plan to address Japan specific needs, together with Marketing and Market Access & aligned with global IBP (Integrated Brand Plan) ・Build new scientific evidence by collaboration with external experts through clinical/pre-clinical researches, investigator initiated studies and RWE (Real World Evidence) studies. ・Contribution to benefit/risk evaluations of products. ・Gain insight from external expert with MSL (Medical Science Liaison) and propose medical strategy.
Minimum Education/Degree Requirements Master's degree in life sciences. MD or PhD preferred. Required Capabilities (Skills, Experience, Competencies) ・TA experience in clinical or research setting, ideally for hepatology, cardiology and Nephrology. ・Experience in clinical development and regulatory interactions related to PMDA consultation and NDA filing and product launch are highly preferred. ・Conceptualization of research and writing scientific papers ・Experience in collaborating and managing key opinion leaders and external exports in respective disease area
700万円〜1,200万円
東京都品川区
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