設立年

1961年 

本社所在地

東京都 

事業内容

医療用医薬品、コンシューマーヘルスケア、アニマルヘルスにわたっており、その中核領域を医療用医薬品において活動 

生産本部　品質統括部　品質管理グループ

募集要項

・品質統括部の方針に基づき、グループの目標・重点施策を遂行する。
・生産に直接関わる原料・バルク・包装資材および最終製品の品質評価を実施し、品質レベルの維持・管理の実務を行う。
・各種依頼試験（工程モニタリング・バリデーション・社内外依頼試験及び苦情調査に関わる試験等）を実施・評価する。
・品質関連事項につき、工場内外の関連部署と連携・調整を図り、品質向上、問題解決を図る。
・Ops Japan及び工場の戦略に基づいてグループに関わるBPE活動を推進し、業務の最適化を提案するとともに後輩を指導する。 

募集条件

【必須】
・法令関連事項（薬事法、GMP、日本薬局方等）実務経験 5年以上、または必要部分の完全理解
・理化学業務（分析化学、有機化学、統計）実務経験 5年以上
・労務管理に関する実務経験5年程度

知識
・法令に関する知識（薬事法、GMP、GMP関連通知、日本薬局方）
・品質管理及び品質保証に関する知識
・薬学及び理化学 (分析化学、有機化学、統計)に関する全般的な知識
・製剤学及び製品に関する基礎的な知識
・会計の基礎知識（管理会計、財務会計）
・労務管理に関する知識
・英語力（複雑な業務を最小の間違いで、英語でうまく扱うことができるレベル）

・学部卒もしくは同等の能力と経験を有する者（専攻：化学、農学、又は薬学系） 

勤務地

山形

生産本部 品質統括部 品質保証グループ スタッフ

募集要項

品質保証グループの方針・目標に基づき、グループの重点施策を提案・実施する。
・GMP システムの構築・維持・向上を行う
・工場内外関連部署及び委託先と連携・調整を図り、円滑な業務遂行を実施する
・業務の信頼性及び効率性の確保・向上を支援する 

募集条件

【必須】
・品質管理及び品質保証分野での5年以上の実務経験
・品質保証業務に関連する知識を有する
・CSV（Computer System Validation）の担当経験
【知識】
・法令関連事項（GMP・日本薬局方・薬事法等）
・物理化学的知識（分析化学・有機化学・統計学）
・製剤及び製品に関する知識
・実務に関係する英文の読み書きができ、ビジネス英会話(担当業務範囲内の説明等)ができる

・化学、薬学、生物学（またはその他の自然科学）の学位 

勤務地

山形

オンコロジー領域メディカルサイエンスリエゾン

募集要項

・To ensure ethical and compliant execution of field based Medicine in Japan for a TA based on scientificobjectives and measures defined in the local integrated brand plans
・To provide scientific information to external expert(EE)/HCPs to support research and medical/scientificinformation needs of EEs/HCPs in their assigned TA
 

募集条件

・Prepare EE list and EE engagment plan
・Identify EEs in respective disease area and revise accordingly
・Prepare appropriate EE engagement plan in the assigned TA in accordance with IBPs and TA strategy
・Ensure with TA tactical execution of strategic scientific objectives as per IBP
・Prepare and submit TA MSL Monthly report include MSL activity metrics and scientific insight summary to head of TA
MSL Group
・Contribute to StARC and other strategic meetings
・Develop and maintain good partnership with external stakeholders throughout product life cycle
・Keep regular contact/communication with the targeted EEs
・Gain scientific insight from external experts on the assigned products
・Prepare an appropriate contents for scientific interview/scientific exchange based on scientific objectives in IBP and align
within TA.
・Conduct scientific interviews/scientific exchange with EEs according to the IBPs to identify the data gap, unmet medical
needs(UMN) and gain other scientific insights
・Share collected scientific insight with TA and other related functions and contribute to scientific insight review meeting for
strategy and action planning
・Support development of data building to fill the gap, taking feasibility, scientific adequacy, and ethical considerations in
account
・Generate the new scientific data to fill the data gap/UMN
・Support investigator initiated clinical/non-clinical studies upon request as a liaison
 

勤務地

東京

Medical Advisor (Non-line manaer)

募集要項

・Contribution to CDPs after proof of concept and late stages of commercialization
・Make contributions to the CDP based on medical need, TA strategy and insights obtained from FBMA
・Prepare local Integrated Brand Plan & Detailed Annual Operational Plan to include Japan specific needs, together with Marketing and Market Access & aligned with global IBP
・Timely availability of local IBP and timely execution of local IBP activities
・Budget control
・Adhere to effective cost management according to budget
・Contribution to benefit/risk evaluations of products
・Availability of adequate benefit / risk evaluations at all documents for products
・Ensure external expert engagement aligned with MSL and according to IBP
・Identify and classify individual customers
・Interact with and engage scientific external experts and societies.
・Maintain close contact with key scientific external experts and societies
・Conduct impact assessment of insights obtained by MSL and share conclusions with Integrated Brand Teams 

募集条件

・Contribute to Strategy and Activity Review Committee meetings.
・Ensure ethics and compliance. Ensure re-examination by reviewing documents and process.
・Plan strategically to allow for effective, safe & medically sound global preparation of drug commercialization efforts.
・Provide input and medical review of all in- and external documentation prepared by Marketing and Public Relations.
・Define trials needed to answer relevant questions regarding products and their related development projects to meet regulatory and payer requirements and commercial needs build upon from the trials concepts developed by the MST&LPT;. Provide medical input into epidemiology studies.
・Ensure communication with CPL.
・Support to obtain preferable pricing.
・TA experience in clinical or research setting.
・Strong negotiation and communication.
・Leadership.
・Japanese: Native
・English: Fluent 

勤務地

東京

製剤開発グループ/Staff

募集要項

・担当プロジェクトの製剤開発を上司の指導に従い行う。
・実験プロトコール，実験報告書を作成する。
・データを適切に文書化および社内データシステムに入力する。
・適宜データを解析し，製剤開発の戦略案を立案する。
・最適な製剤処方，包装形態を模索検討し，頑健な製造プロセスを確立する。
・当局に提出する文書（CTD, IMPDなど）の案を作成し，信頼性確保を行う。
・担当機器について必要な保守管理を行う。
・原薬，製剤添加剤を適切に保管，管理する。
・生産部門（工場）またはその他のR&Dへの製造方法の移管を，上司の指示に従い実施する。
・治験薬の外部委託製造及び包装を担当する。

＜責任＞
・実験プロトコール，実験報告書をタイムリーに作成し，又， 社内データシステムに正しく入力する責任がある。
・部屋や機器の使用記録を付け，適切に使用，清掃，保管する責任がある。
・生データ及び加工データのチェックを適切に行い，当局に提出する文書（CTD, IMPDなど）や会議用資料の信頼性確保を行う責任がある。
・治験薬関連の書類（MS, 外部委託製造・包装関連書類）を間違いなく，タイムリーに作成する責任がある。
・法，規則，GMP，SOP，WI, EHSおよび安全等の規則を遵守する責任がある。
・上司および同僚への報告・連絡・相談を怠ることなく，適切に行う責任がある。
・担当機器について適切に保守管理を行う責任がある。

 

募集条件

・薬学，理学，工学，農学等における分析学，有機化学，物理化学，製剤学等の学位（修士以上、博士が望ましい）
・3-10年程度の固形製剤分析研究の業務経験，申請業務
・国際コミュニケーションスキル
・ビジネス中級レベル：複雑な業務を最小の間違いで，英語でうまく扱うことができる
 

勤務地

兵庫

MSL

募集要項

・Prepare EE list and EE engagement plan
・Identify EEs in respective disease area and revise accordingly
・Prepare appropriate EE engagement plan in the assigned TA in accordance with IBPs and TA strategy
・Ensure with TA tactical execution of strategic scientific objectives as per IBP
・Prepare and submit TA MSL Monthly report include MSL activity metrics and scientific insight summary to head of TA MSL group
・Contribute to StARC and other strategic meetings
・Develop and maintain good partnership with external stakeholders throughout product life cycle
・Keep regular contact/communication with the targeted EEs
・Gain scientific insight from external experts on the assigned products
・Prepare an appropriate contents for scientific interview/scientific exchange based on scientific objectives in IBP and align within TA.
・Conduct scientific interviews/scientific exchange with EEs according to the IBPs to identify the data gap, unmet medical needs(UMN) and gain other scientific insights
・Share collected scientific insight with TA and other related functions and contribute to scientific insight review meeting for strategy and action planning
・Support development of data building to fill the gap, taking feasibility, scientific adequacy, and ethical considerations in account
・Generate the new scientific data to fill the data gap/UMN
・Support investigator initiated clinical/non-clinical studies upon request as a liaison
・Provide scientific information regarding the on/off label and un-approved drug to external customers on request basis
・Prepare an appropriate contents and align within TA
・Respond to scientific queries requested by external expert or other external customer in an appropriate timing
・Support organizing advisory board meetings or other activities which are planned and executed by TA
・Prepare appropriate plan in the assigned area in accordance with in IBP and TA strategy
・Plan and hold scientific symposium in collaborate with congress group and Medicine excellence group
・Supervise MSL staff member and contribute to budget control
・Supervise MSL staff member when required trainning or support
・Adhere to effective cost management according to budget 

募集条件

・PhD, MD, MBA, MSc
・Major in Medicine
・Japan in-house coaching skill （社内コーチングスキル）
・TA experience in clinical or research setting
・5+ years industry experience in Japan
・Strong negotiation and communication
・Leadership
・Japanese speaking
・English: Read-Good, Write-Basic, Speak-Basic (Clear understanding from scientific publication is required in assigned TA)

 

勤務地

東京、大阪

製剤分析研究部

募集要項

経口固形製剤のHPLC分析方法の開発及び試験の実施
・HPLC等による分析方法の開発と試験方法に基づく分析試験の実施
・安定性試験の立案，実施
・治験薬の品質試験
・臨床試験及び承認申請に必要な分析関連文書の作成
 

募集条件

・修士卒レベル以上（自然科学系分野）
・英語スキル（英語で業務を遂行できるレベル）
・GMP等に関連する法令，規制，およびICH等ガイドラインに関する知識
・分析方法開発に関する高度な知識
・書面および口頭でのコミュニケーションを含む優れた対人関係能力
・経口固形製剤等の医薬品製剤分析における実務経験（尚可）
 

勤務地

兵庫

Medical Science Liansion（オンコロジー）

募集要項

Prepare EE list and EE engagement plan
・Identify EEs in respective disease area and revise accordingly
・Prepare appropriate EE engagement plan in the assigned TA in accordance with IBPs and TA strategy
・Ensure with TA tactical execution of strategic scientific objectives as per IBP
・Prepare and submit TA MSL Monthly report include MSL activity metrics and scientific insight summary to head of TA MSL group
・Contribute to StARC and other strategic meetings
・Develop and maintain good partnership with external stakeholders throughout product life cycle
・Keep regular contact/communication with the targeted EEs
・Gain scientific insight from external experts on the assigned products
・Prepare an appropriate contents for scientific interview/scientific exchange based on scientific objectives in IBP and align within TA.
・Conduct scientific interviews/scientific exchange with EEs according to the IBPs to identify the data gap, unmet medical needs(UMN) and gain other scientific insights
・Share collected scientific insight with TA and other related functions and contribute to scientific insight review meeting for strategy and action planning
・Support development of data building to fill the gap, taking feasibility, scientific adequacy, and ethical considerations in account
・Generate the new scientific data to fill the data gap/UMN
・Support investigator initiated clinical/non-clinical studies upon request as a liaison
・Provide scientific information regarding the on/off label and un-approved drug to external customers on request basis
・Prepare an appropriate contents and align within TA
・Respond to scientific queries requested by external expert or other external customer in an appropriate timing
・Support organizing advisory board meetings or other activities which are planned and executed by TA
・Prepare appropriate plan in the assigned area in accordance with in IBP and TA strategy
・Plan and hold scientific symposium in collaborate with congress group and Medicine excellence group
・Budget control
・Adhere to effective cost management according to budget 

募集条件

・PhD, MD, MBA, MSc
・Major in Medicine
・TA experience in clinical or research setting
・5+ years industry experience in Japan
・Strong negotiation and communication
・Leadership
・Japanese speaking
・English: Read-Good, Write-Basic, Speak-Basic (Clear understanding from scientific publication is required in assigned TA) 

勤務地

東京

Medical Science Liansion（循環器）

募集要項

・Prepare EE list and EE engagement plan
・Identify EEs in respective disease area and revise accordingly
・Prepare appropriate EE engagement plan in the assigned TA in accordance with IBPs and TA strategy
・Ensure with TA tactical execution of strategic scientific objectives as per IBP
・Prepare and submit TA MSL Monthly report include MSL activity metrics and scientific insight summary to head of TA MSL group
・Contribute to StARC and other strategic meetings
・Develop and maintain good partnership with external stakeholders throughout product life cycle
・Keep regular contact/communication with the targeted EEs
・Gain scientific insight from external experts on the assigned products
・Prepare an appropriate contents for scientific interview/scientific exchange based on scientific objectives in IBP and align within TA.
・Conduct scientific interviews/scientific exchange with EEs according to the IBPs to identify the data gap, unmet medical needs(UMN) and gain other scientific insights
・Share collected scientific insight with TA and other related functions and contribute to scientific insight review meeting for strategy and action planning
・Support development of data building to fill the gap, taking feasibility, scientific adequacy, and ethical considerations in account
・Generate the new scientific data to fill the data gap/UMN
・Support investigator initiated clinical/non-clinical studies upon request as a liaison
・Provide scientific information regarding the on/off label and un-approved drug to external customers on request basis
・Prepare an appropriate contents and align within TA
・Respond to scientific queries requested by external expert or other external customer in an appropriate timing
・Support organizing advisory board meetings or other activities which are planned and executed by TA
・Prepare appropriate plan in the assigned area in accordance with in IBP and TA strategy
・Plan and hold scientific symposium in collaborate with congress group and Medicine excellence group
・Budget control
・Adhere to effective cost management according to budget 

募集条件

・PhD, MD, MBA, MSc
・Major in Medicine
・BI Japan in-house coaching skill （BI Japan 社内コーチングスキル）
・TA experience in clinical or research setting
・5+ years industry experience in Japan
・Strong negotiation and communication
・Leadership 

勤務地

東京