Job Description グローバル研究開発本部 薬事領域スタッフとして、バイオ医薬品・ワクチンの新薬の開発開始から承認申請及び承認取得、並びに剤形追加及び変更管理に至るまでのCMC薬事業務に貢献していただける担当者を求めています。最先端のCMC技術を取り入れた製品開発や、製薬業界において注目されているCMC薬事関連トピックの協議に最前線で関与できる幅広い機会があります。 米国本社等のCMC薬事担当者と協働し、担当品のCMC開発ステージを適正に前進させ、論理的で科学的に質の高い承認申請資料のCMCパート（製造方法、規格及び試験方法、並びに安定性等）を作成する。 製品に関するCMC上の問題点の抽出及びリスク評価、並びにその対応策の作成を行う。 規制当局又は業界団体より入手したCMC薬事情報を国内・海外関連部門へ提供し、協議を行う。 CMCに係わる変更情報を評価し、必要に応じ適切に薬事対応を行う。 当局相談あるいは承認審査において、適切に照会対応を行い、必要に応じて交渉を行う。 海外出張や電話会議において、米国本社又は海外サイトの関係者と連携し、CMC関連事項の戦略的対応策を作成する。 必要な資格、資質 CMCラボ・パイロットでの原薬・製剤又は分析の実務経験、あるいはCMC薬事実務経験 医学、薬学、化学、生物学等の修士卒以上 実務レベルの英会話能力（TOEIC700以上） 望ましい資格、資質 海外とのコミュニケーション経験 ※今回はR2若しくはR3での採用となります。 Additional location(s) Compensation Information: Required Skills: Action-Oriented, Adverse Event Report, Compliance Investigations, Detail-Oriented, Employee Training Programs, Labeling Compliance, Negotiation,
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At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Sales Representative Dermatology Japan Region to join our commercial team, supporting
. MAIN FOCUS AND MISSION: ・Contribution to Simultaneous development and submission across US, EU and Japan for Servier’s new drugs through medical writing activities ・メディカルライティング業務を通じて、セルヴィエグループの新薬について米国、欧州および日本での同時開発・同時申請に貢献する ROLE & RESPONSIBILITIES: ・Preparation of high-quality new drug applications, including domestic
Job Description Summary-Lead scientific engagement with their Medical Experts. Implement clinical and educational strategies and respond to unsolicited medical enquiries. Job Description 主な役割責任： l Develop and execute strategic field medical plans across assigned therapeutic areas and
＜Areas＞・Hematology & Nephrology Position Summary The “Senior Manager, Medical Science Liaison (MSL)” is a field-based scientific expert that strategically supports the medical and scientific objectives of Alexion’s product/indication(s) across the product/s life cycle. He/she is
＜Areas＞ ・Hematology & Nephrology Position Summary The “Senior Manager, Medical Science Liaison (MSL)” is a field-based scientific expert that strategically supports the medical and scientific objectives of Alexion’s product/indication(s) across the product/s life cycle. He/she
About us BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse
For nearly 30 years, SQA Services has been a leading provider of managed supplier quality services, offering audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across all industries. We deliver these
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Sales Representative Immunology Dermatology Japan to join our Immunology Commercial Team,
Job Description SummaryLead one of ten areas that together cover the entire country within the newly created Biosimilar Department in Japan, with responsibility for ten MRs in the assigned area. Translate the Biosimilar Department strategy into
Our Why At Dotmatics At Dotmatics, a Siemens company, we believe science, data, and decision-making must be deeply intertwined for innovation to thrive. Our Portfolio includes Luma, LumaLab Connect, ELN Platform, Graphpad Prism, Geneious, SnapGene, Protein
Project Manager/ BioReliance® Contract Testing Services, Life Science Services Location: Tokyo Report to: Manager in Japan Direct report: 0 ABOUT BioReliance® Contract Testing Services BioReliance® Testing Services provides testing and manufacturing services to pharmaceutical and biopharmaceutical
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sales Specialist II Rare Disease Genetic Hearing Loss Japan to join our
About GenScript Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its