外資系大手製薬メーカー　メディカルアドバイザー(肥満症/MASH領域)/ ノンラインマネージャー or スタッフ / 医薬開発本部

資格・要件

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
・Strong negotiation and communication skills for internal and external stakeholders in Japan and global
・Good project management and excellent cross functional collaboration skills with ability to work with global matrix teams
・Experience in leading a team project (evidence generation, new drug launch/approval, collaboration with external stakeholders) / people management are preferred .
・English speaking (at least TOEIC >800)
・Knowledge about the regulations related with clinical research/clinical trial/clinical development

職務内容

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 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 global 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 company's global medicine as well aligned with global development strategy in the respective therapeutic area
・Support the company 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.

【その他情報】
契約期間：期間の定めなし
試用期間：3か月
就業時間：8:45～17:20
休憩時間：45分
フレキシブルタイム：あり フルフレックス
時間外労働：あり
休日休暇：
完全週休2日制（休日は土日祝日）
年間有給休暇　あり（入社初年度は入社月により変動）
年間休日日数128日
受動喫煙対策：屋内全面禁煙
加入保険：雇用・労災・健康・厚生年金保険
在宅勤務制度：あり