ワクチン、オンコロジー領域での新薬の承認取得を通して、日本の患者さんにイノベイティブな治療を提供することに貢献できる業務です。 新薬開発及びライフサイクルマネジメントにおいて、薬事戦略を立案/実行する。 薬事関連規制や関連する事例等を考慮した薬事戦略を立案し、チームメンバーと協働して実行する。 承認申請や対面助言等、薬事関連業務をリードし、規制当局との交渉戦略を立案/実行する。 薬事的課題を分析し、適切な解決策を提案/実行する。 海外チームと良好な信頼関係を築き、薬事関連規制や薬事戦略の提供を実行する。 海外薬事規制等を踏まえた国内薬事規制の問題点を提示する。 規制当局と良好な信頼関係を築き、適切なコミュニケーションと薬事的交渉を実行する。 規制当局との交渉の場において議論内容をリードする。 ※職務内容および勤務地の変更範囲は会社の定めるところとする。 必要な条件 Basic Qualification スキル Skill 薬機法の体系、開発・承認審査の概略に関する知識 プロジェクトチームや規制当局で開発薬事戦略を説明するコミュニケーション力 グローバルコミュニケーション力（英語での理論構築、読み・書き・会話力） 経験 Experience 医薬品等の開発関連業務に合計3年以上携わった経験 学位/資格/語学力 Education/Certification/Language 医学、薬学、生物学、科学等での学士もしくはそれと同等以上 望ましい条件 Preferred Qualification スキル Skill ロジカルシンキング 既成概念にとらわれない思考 変化を積極的に受け入れ、挑戦し、実行する姿勢 経験 Experience 医薬品等の承認申請・対面助言関連業務 学位/資格/語学力 Education/Certification/Language 修士、博士もしくはそれと同等以上
Family Description Customer Services (CS) covers customer service in different areas such as technical support, account support, operations, maintenance, network design / deployment / integration / transformation, and education. Generates revenue and the increase of customer satisfaction
Leidos is hiring licensed behavioral health professionals to join our Adult Military and Family Life Counseling (MFLC) team to support at Iwakuni in Japan. December 2024 start date. Join the mission to support U.S. military service members
Leidos is hiring licensed behavioral health professionals to join our Military and Family Life Counselor (MFLC) Child and Youth Behavioral team to support in Yokosuka, Japan . This is a 9 month school calendar position that will
Job purpose Responsible for driving commercial success of Depemokimab in Japan LOC. Member of the Global/LOC cross-functional shaping global strategy and co-creation Key responsibilities Understand global strategy and initiatives, as well as local environment and insights
Job Overview Secure and retain business through professional, consultative, proactive sales activities directed at decision-makers and decision influencers at existing and new clinical sponsors. Will be responsible for multiple CRO line-of-businesses, including clinical trial outsourcing, pharmacovigilance
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 最適な流通モデルを検討する際の安定供給、Financial benefitの面からの評価 流通改善ガイドライン、その他法規制に基づいた価格体系（仕切価、割戻し、Net sales）の立案 新製品の価格体系の提案および承認取得、送品スケジュールの管理と出荷数量の試算 法令、コンプライアンスを遵守した製品価値の最適化を実現するための特約店担当者の活動プランの立案と管理 特約店へのPrimary salesの異常発注等のMonitoringを通した不動在庫・偏在を抽出するためのプランの作成 回収、欠品等に伴う流通障害の際、関連部署とともにGSK製品の安定供給に最大限寄与する流通戦略の立案とGSKの方針を特約店に理解してもらうための説明資料作成 特約店による製品プロモーションを実施する場合は、管轄地域において営業と協力し効果的・効率的なコミュニケーションを実施、成果の最大化。 管轄地域において部下が上記を遂行するための指導・教育 特約店との新しい関係、働き方（リモートコミュニケーション等）の推進とそのためのメンバーのマインドセット変革 GSK culture浸透のためのinitiative企画、提案、実施 Employee engagement向上のためのinitiative企画、提案、実施 ※職務内容および勤務地の変更範囲は会社の定めるところとする。 必要要件 Required Skill, Experience, Etc. 必要な条件Basic Qualification スキル Skill 特約店の業務内容に関する基礎的な知識 流通全般における業界団体からの通知・ガイドラインに関する基礎的な知識 売上・コスト等の数字の分析スキル 交渉スキル（社内外）
We are a leading chemical company, with the best teams developing intelligent solutions for our customers, and for a sustainable future. We connect and develop people with diverse talents all over the world. For you, this
We are a leading chemical company, with the best teams developing intelligent solutions for our customers, and for a sustainable future. We connect and develop people with diverse talents all over the world. For you, this
We are a leading chemical company, with the best teams developing intelligent solutions for our customers, and for a sustainable future. We connect and develop people with diverse talents all over the world. For you, this
Objectives of the Position As expert in corporate Environment, Health and Safety, assist Business Units in improving and maintaining EHS performance of BASF Japan (BJL) and group companies located in Japan. Applicable subject matters (not necessary for
Objectives of the Position As expert in corporate Environment, Health and Safety, assist Business Units in improving and maintaining EHS performance of BASF Japan (BJL) and group companies located in Japan. Applicable subject matters (not necessary for
Leidos is hiring licensed behavioral health professionals to join our Child and Youth Behavioral, Military and Family Life Counselor (MFLC) team to support at Misawa. Join the mission to support U.S. military service members and their families
Company Description Are you ready to trade your job for a journey? Become a FlyMate! Passion, excitement & global collaboration are all core to what it means to be a FlyMate. At Flywire, we’re on a
Job Purpose As part of Japan Vaccine marketing team, digital marketing manager (consumer focus) is responsible for contributing to the development and implementation of digital marketing activities of vaccine preventable disease awareness campaign. Actions should be
Job Purpose As part of Japan Vaccine marketing team, consumer engagement manager (consumer focus/offline) leads the development and implementation of disease awareness campaign for consumers. Actions should be in line with overall non-promotional marketing strategy and
【Main Areas of Responsibilities and Key Activities】 ■Quality support: Act as QA in BJL-GMP organization and maintain local GMP warehouse for import pharma goods. Monitoring and understanding relevant laws and regulations related GMP/Quality management. Support /
About the Role: Join GSK Global as a Senior AI/ML Engineer and lead the development and automation of AI/ML applications and platforms that drive our global business units and local markets. Work with cutting-edge technologies like
We are looking for a Site Manager to join our newly establish Service team in the Vestas Offshore Japan. If you would like to work in an international and innovative company where we work shoulder to
We are looking for a Site Manager to join our newly establish Service team in the Vestas Offshore Japan. If you would like to work in an international and innovative company where we work shoulder to
