外資系大手製薬メーカー メディカルアドバイザー/医薬開発本部クリニカルデベロップメント・メディカルアフェアーズ心・腎・代謝領域メディシン第３部（肥満症/MASH領域）
- 会社区別外資系製薬メーカー
- 職種メディカルドクター
- 勤務地本社（東京都品川区）
- 年収700万円～1,300万円
資格・要件
Minimum Education/Degree Requirements
A Master’s degree in life sciences. MD or PhD is preferred.
Capabilities (Skills, Experience, Competencies)
・Good communication and negotiation skills for internal and external stakeholders in Japan and global (required).
・TA experience in clinical or research setting, ideally for a liver-related disease and metabolic diseases such as obesity and diabetes (strongly preferred).
・Experience in collaborating and managing key opinion leaders and external exports in respective disease area (preferred).
・Experience in conceptualization of pre-clinical or clinical research and in developing scientific manuscript (preferred).
・English communication skills (preferred CEFR B2 or above).
・Experience in medical product launch is plus.
・Knowledge about the regulations related to clinical research/clinical trial/clinical development is plus
・Experience in clinical development and regulatory interactions related to PMDA consultation and NDA filing and product launch are plus.
Regarding publications
・Please submit list of key publications, if possible I relation to this field.
職務内容
Basic purpose of the job
To plan and execute CDMA (Clinical Development & Medical Affairs) activities in Japan according to TA (Therapeutic Area) strategy. Confirmed target indication: Obesity disease, MASH (Metabolic dysfunction associated steatohepatitis).
Accountabilities
・Gain insight from external expert (EE) with MSL (Medical Science Liaison) and propose medical activity based on identified medical gap.
・Build new scientific evidence by collaboration with external experts through clinical/pre-clinical researches, investigator initiated studies and RWE (Real World Evidence) studies including PMS.
・Prepare Integrated Asset Plan (IAP) & Detailed Annual Communication Plan to address Japan specific needs, together with Marketing and Market Access & aligned with global IAP.
・Support NBI make development/data building decision based on total picture (all projects/trials in the respects of resource/budget) in the TA.
・Strengthen NBI products’ profile by providing medical/scientific robust guidance in the responsible TA through the total process of the clinical development phases, in collaboration with BI 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 BI global medicine as well aligned with global development strategy in the respective TA
・Contribution to CDPs (Clinical Data Packages) after proof of concept and late stages of commercialization with medical perspective.
・Contribution to benefit/risk evaluations of products.
・To understand and comply with regulations and industry rules (promotional codes, fair competition rules, privacy, data collection/storage, etc.) as well as related SOP.
【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
【将来的に従事する可能性のある職務内容】会社の定める職務
＜将来的に勤務する可能性のある場所＞会社の定める事業拠点（テレワークを行う場所を含む）
