Job Title: Occupational Therapist Department/Group: Education Position type Fulltime Location: Kakuma Reports to: Education Technical Lead The Department of World Service (WS) of the Lutheran World Federation (LWF) is the humanitarian and development arm of the
Responsibility: バイオ品の新薬申請及び市販製品の変更管理におけるCMC薬事戦略を構築する バイオ品の新薬申請及び市販製品の変更管理におけるCMCのレギュラトリーリスクを時宜特定し、対応策を立案する 高品質のCMC承認申請資料を作成する。 規制当局からの照会事項に対してタイムリーな回答作成を行う。 バイオ品の新薬申請及び市販製品の変更管理におけるタイムリーな承認に寄与する 最新のCMC薬事情報の把握と規制当局及び業界への高い影響力を持つ。 Role: GSK Japanの開発品目におけるグローバル統一のCMC承認要件の実現かつ迅速な承認取得を目的としたCMC薬事戦略の構築、並びに市販製品の一部変更承認申請、軽微変更届出において、提言、方針決定、関連部署との交渉、必要に応じリソース配分等を自らも行い上司のサポートも行う。 当局対応において、承認時期への影響、GSKにおける承認後のグローバルビジネス及び国内での市販品の供給への影響等を鑑み、方針決定を行う、あるいはその提言を上司に行う。 他部署との協力業務におけるプロセス上の問題(役割分担等)の解決・調整をリードし、GSKとしてより良いプロセスを構築する、あるいはその提言を上司に行う。 複数の製品に共通のCMC関連課題/問題につき、海外関連部署と必要な協議を行う。 複数のproject team に対してCMC RA を代表したCMC薬事戦略の提案・提言を行う。 業界団体・学術団体等を通じCMCに関する規制調和を推進する。 Basic Qualification Skill 日本語又は英語により円滑なコミュニケーションのできる方 共に学びながら成長したい方 分析化学、有機化学または製剤・薬剤学(特に製造方法あるいはGMP)・生物学に関する知識がある方 Experience 企業での業務経験のある方(分析、製造、CMC薬事、開発等)(3年以上が望ましい) Education/certification/Language 医学、薬学、生物学、物理科学等での学士もしくはそれと同等以上 Preferred Qualification Skill 英語環境での理論構築、読み書き、会話力等 Experience CMC薬事業務の経験 Why
Are you interested in improving the lives of millions of people, contributing to a company that works with innovation and is a pioneer in addressing the unmet medical needs? Do you have an innovative mindset to
■ 職務内容 / Job Description Drive development and execution of external communications strategy to drive a corporate reputation and advance science and therapeutic area leadership of AZKK. Leads a team of external communication managers and specialists covering corporate
Job Description Summary -Lead the country Franchise Medical Team, develop the Franchise Medical Strategy and executes it through and operational Medical Plan. Coach and develop team members as well as represent Medical in country Franchise Leadership
Job Description [Position/ ポジション名] 渉外本部 Public Affairs Manager or Assistant Manager [Responsibilities/ 職務内容] Public Affairs Manager/Assistant Manager implements the business strategy, engagement, and activation of external stakeholders who drive or influence the policies that determine our
Job Description Summary Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and local areas under the direction and agreement of the Group manager. Job Description Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and local areas under the
About Klick HealthMeet a different kind of workplace. Klick Health is an ecosystem of brilliant minds working to realize the full potential of their people and clients in life sciences since 1997. And we’re still growing
Job Overview Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of
Job Purpose: Plan and execute the marketing strategy and tactics to ensure commercial success of the product Key Responsibilities: To strategically drive “Shape the market” & “Shape the product”, work with brand lead to develop and
Job Description Summary ・Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and local areas under the direction and agreement of the Group manager. Job Description Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and local areas under the
■ 職務内容 / Job Description Medical Communication Scientist (MCS) is a role name in AZKK and is generally known as medical writer. MCS is responsible for the authoring of clinical-regulatory documents and submission packages that communicate
Responsibility: Co-develop global medical strategy to cater local unmet medical needs Support local EE network development and transfer of relationship ownership to Vaccine and Infectious Disease team Deep capabilities of MSLs to have a meaningful exchange
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
Title: Medical Advisor / Medical Scientific Liaison FOP Company: IPSEN K.K. Job Description: As part of the Medical Affairs department, the MA/MSL is a hybrid, field-based scientific expert to external and internal stakeholders delivering non-promotional information
Job Description The position takes a responsibility for medical contents in all clinical development programs in assigned therapeutic areas (such as dementia, movement disorders, neuromuscular, and MS/Immunology etc.) in Japan. The individual functions as a scientific and clinical
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
Job Purpose: Responsible for driving commercial success in Japan LOC by leading GSK X-functional team Member of the Global/LOC cross-functional, shaping global strategy and co-creation Key Responsibilities: Understand global strategy and initiatives, as well as local
Job Purpose Background: Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. To achieve our ambitious
About Springer Nature Group Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions of people. For