ジョンソン•エンド•ジョンソンは,健康こそすべてだと考えています。ヘルスケアイノベーションにおける私たちの強みが,複雑な病を予防•治療•治癒し,治療をよりスマート化した,低侵襲なものに進化させ,一人ひとりの患者さんに合ったソリューションを提供することができる世界を築く力になります。 Innovative MedicineとMedTechにおける専門性を生かし,将来の飛躍的な進化に向けてヘルスケアソリューションの幅広い領域でイノベーションを推し進め,人々の健康に大きなインパクトを与えていきます。https://www.jnj.com/ 職務概要 Position Summary: 複数のラインでの検査,包装工程における安全,品質,供給の全分野における要求事項の達 成に向けてチームをリードする。 Lead the team in the multiple inspection/packaging lines to achieve all requirements in safety, quality, and supply. 法規制の順守に関する責任 Regulatory Compliance Responsibilities: 全ての従業員はコンプライアンスの順守を最優先にしなくてはならない。 All employees must concern compliance as
About Johnson & Johnson At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive,
職務 概要 Position Summary : 1. The launch of new technology, products and technical transfers. 2. The validation process and execution (Process and Cleaning Validation). This includes lifecycle management of products (including continuous improvement). 3. Packaging
Work ScheduleOther Environmental ConditionsOffice Job Description At Thermo Fisher Scientific, each one of our 125,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the
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
Job Description The Senior Manager / Manager of Clinical Pharmacology in Clinical Pharmacology & Pharmacometrics (CPP) serves as the clinical pharmacology country lead on program, clinical pharmacology, and clinical study teams, providing strategic leadership and expertise
Job Description Responsible for all activities of Japan regulatory operations as a lead of regulatory operation in collaboration with Global RA, Japan R&D, and other functional areas within Biogen. Manage and maintain regulatory operational activities in
Primary Responsibilities Assists Clinical Project Managers with project administration by: Developing project related documents Reviewing and editing project presentations Participating in project meetings, conference calls, and training calls Reading and understanding project protocol documents Acting as
A Career at HARMAN As a technology leader that is rapidly on the move, HARMAN is filled with people who are focused on making life better. Innovation, inclusivity and teamwork are a part of our DNA.
The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, youll be part
About Johnson & Johnson At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive,
About Johnson & Johnson At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive,
Regulatory Affairs Manager CH Japan YOUR TASKS AND RESPONSIBILITIES: Determine local regulatory strategies and manage operational tasks to fulfill the local business strategies for the CH portfolio, in coordination with local functions and with close coordination
Regulatory Affairs Manager CH Japan YOUR TASKS AND RESPONSIBILITIES: Determine local regulatory strategies and manage operational tasks to fulfill the local business strategies for the CH portfolio, in coordination with local functions and with close coordination
Are you seeking a role where your knowledge and experience in global trade tariffs / customs will be fully utilized. Would you like to be working on multiple projects during the requirement gathering and testing stage?
Job Description: Key responsibilities: Liaises and supports development of KEEs Provides high quality medical and scientific support/communications to internal and external customers (e.g. advisory board meetings, training courses/workshops together with KEEs, support of speakers with presentations and
Job Description Summary ・BSの薬事開発から承認取得及び市販後のメンテナンスまでの薬事戦略を立案の上で実行する。 ・BS医薬品の上市、メンテナンス及び安定供給に貢献できるマネジャー職 ・BSの薬事業務について国内及びGlobal関係者をリードする Job Description Major accountabilities: 1) 複数のBSプロジェクトの進捗に貢献する 2) 他のメンバーが担当するBSプロジェクトをサポートする 3) BSのPMDA相談の成功及び承認取得のための薬事戦略案を策定し、Global teamに提示し、Global teamの計画と統合する 4) BSのGlobal team及びSKK関係者をリードし、PMDA相談や国内承認申請（一変を含む）の準備を進め実施する 5) 薬事関連業務について、Global 及び 国内の社内関係者をリードして業務を取りまとめ、業務目標を達成する 6) 規制当局（PMDA、MHLW等）との交渉をリードする 7) 外部委託先を管理する Key performance indicators: ・製薬会社で5年以上の薬事経験（開発薬事又はCMC薬事）を有する又は 生物製剤のCMCに関する日本の規制に精通している • プロジェクトの状況と日本の規制を考慮した薬事戦略の提案ができる
We are looking for a Senior Drug Safety Manager with a strong background in GVP operational experience. This role will provide an opportunity to ensure our systems matter by updating procedures with our Japanese partners and working
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.
