Job Description Summary -Responsible for all statistical programming/data review reporting and analytics development aspects of assigned studies or project-level activities. Acts as a key contributor in ensuring that drug-development plans are executed efficiently with timely and high quality
Regulatory Lead Location: Tokyo About the job DEPARTMENT: Regulatory, Science Hub Japan REPORTS TO: Head of Regulatory BASIC FUNCTION: Inspiring professional who will leverage his/her regulatory experience and commercial awareness to proactively contribute to CHC business
Job Description Summary -Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of
Job Purpose: The Clinical Scientist (CS) is the single point accountability for the development of the Clinical Development Plan (CDP) and study design, interpretation of study results, as well as creation of filing strategy and documents of clinical
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring
※This position requires native level Japanese and Business Level English JOB SUMMARY The HR Manager directs and works with Human Resources and Operations employees to carry out the daily activities of the Human Resource Office including
Do you offer internal recruitment experience in Japan, ideally with a strong focus on B2B recruitment in the technology or media domains? Are you keen to ensure a great candidate experience, collaborate with a tight team
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
Job Description Summary -Lead scientific engagement with their Medical Experts. Implement clinical and educational strategies and respond to unsolicited medical enquiries. Lead field medical activities in collaboration with cross-functional teams and mentor other Field Medical associates.
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
Join our dynamic team in Tokyo as a HR Manager and play a pivotal role in shaping our organizations culture and driving business success! Reporting to the HR Director based in Tokyo, you will serve as
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JOB SUMMARY As a member of the property Human Resources support staff, he/she works with Human Resources employees to carry out the daily activities of the Human Resource Office including oversight of recruitment, total compensation, and
About Us Diligent is the global leader in modern governance, providing SaaS solutions across governance, risk, compliance, audit and ESG. Empowering more than 1 million users and 700,000 board members and leaders with a holistic view
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 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
ジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。 Position Summary: The Japan Regulatory Leader (or This position) is primarily responsible for the development of Japan regulatory strategy to advance Genmab’s portfolio of development pipeline candidates and life cycle management of marketed products in collaboration with
Job Description Summary The Study Leader is the leader of the cross-functional clinical trial team (CTT), guides planning andmanagement of the assigned clinical study/studies end-to-end to achieve Global Program Team(GPT), Global Clinical Team (GOT) and GCO
■ 職務内容 / Job Description Description: The PS Epidemiologist (PSEPI) serves as a study lead for Post Authorization Regulatory Commitment Studies (PARCS) including post-marketing database study and use-result survey, accelerating the generation of valuable real-world evidence.
Do you have experience in Account management, Client Management or Customer Success for a enterprise software solution? Are you keen to join a hyper growth business offering a fantastic career path? The Senior Client Relationship Manager