Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
職務の目的 規制当局及び社内関連部署と良好な関係を築き、規制当局との窓口業務を適切に遂行し、承認前GMP適合性調査、定期的なGMP適合性調査及び外国製造業者認定の新規取得／管理を確実に行う。 主な業務内容 下記業務における規制当局窓口業務（申請・照会事項対応） 新薬申請時の承認前GMP適合性調査 一部変更承認申請時の承認前GMP適合性調査 定期GMP適合性調査 外国製造業者認定 新規申請・更新・変更 必要な条件 海外と口頭でコミュニケーションができる最低限の英語力（リスニング、スピーキング）（TOEIC600点～） 社内関連部署及び当局と交渉するためのコミュニケーション能力 スケジュール管理能力 製薬業における業務経験 リーダーシップ 望ましい条件 高度な英語力（TOEIC700点～） 医薬品製造・品質保証に関する知識・経験 医薬品製造販売承認申請書に関する知識・経験 GMPに関する知識・経験 ピープルマネジメントの経験 Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied
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
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
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
I – JOB INFORMATION Job Title: External Manufacturing Vx PPM and Operations Lead, Japan Effective Date: 3/1/2025 Department: External Manufacturing, Japan Division: EM&S Reports to: Head External Manufacturing Japan Location: Hatsudai, Tokyo. II - JOB SUMMARY
Job purpose · Responsible for implementing the Medical Affairs Plan of specified Team strategies, driving a consistent approach to carrying out scientific engagement activities internally and in the field; ensuring compliance with all relevant regulations and GSK
Job Purpose The Public Relations Expert formulates short, medium, and long-term measures (advocacy strategies) and coordinates and organizes activities both inside and outside the company, whether branded or non-branded, to deliver medicines and vaccines to patients.
Main duties and responsibilities Airport stakeholders’ relationship management Build and maintain positive and effective relationships with Airport management, Customs and all relevant stakeholders Lead key negotiations with airport, customs, agents and related stakeholders make contracts with
＊スペシャリティ・ジェネラルメディスン領域での開発薬事業務及びスペシャリティ・ジェネラルメディスン薬事部（SGMRA）/オンコロジー・ワクチン薬事部（OVRA）の両部横断的な活動業務及び人財育成をリードする役割を担当していただきます。 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。 上記業務のほか、SGMRA及びOVRA両部横断的な活動業務及び人財育成をリードする（例：Hyper acceleration, GRA Japan/China Focus Group, Japanese Regulations Training for GRA等）。 SGMRA及びOVRA両部横断的な活動において、戦略構築における各担当者に対するアドバイスを含む、担当プロジェクトを成功させるために必要な支援を提供する。 Line Managerと共に他のSGMRA及びOVRA担当者の業務に関するアドバイス及びメンタリングなどによりSGMRA及びOVRA各担当者の成長を支援する。 ※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） 難易度の高いプロジェクトや国内外ともにステークホルダーが多いプロジェクトであっても、プロジェクトチーム内外のステークホルダーとの調整を遂行するスキル 高難度のプロジェクトにおいても薬事が主担当となる業務を超えて担当プロジェクトチームをリード/サポートすることができる高度な、リーダーシップスキル 経験 Experience 医薬品等の開発関連業務
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Job purpose Medical Science Liaison (MSL) is a field-based role in the new Medical organization, reporting to MSL manager. In order to build a trust with External Experts (EE) and scientific community, MSL needs to play a
Job purpose: GSK Japan is searching for a Manager, Medical Science Liaison (MSL) within Medical Affairs to support the hepatology therapeutic area. This individual will be responsible for leading MSLs in achieving excellence in scientific engagement, ensuring good
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a
Are you interested in a regulatory affairs role that allows you to mitigate risk and accelerate compliance across the business? If so, this Regulatory Compliance Manager could be an ideal opportunity to explore. As a Regulatory Compliance Manager Professional, you will be
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases
For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases
