ベーリンガーインゲルハイム製薬株式会社 勤務地：大崎オフィス（国内出張あり） ＊日本語の応募書類に加え、できれば英語CVもご送付をいただけますと幸いです。 1. CMOにて発生する各種変更(原薬・副原料・機器等)に対して、CMOからのQualification計画を製剤技術の観点からReviewし、実行する。 （工業化検討・PQ/PV計画書/報告書Review, 必要に応じて現場立会い） 同様にCMOと協議し、Process堅牢化・改善を進める。 2. 新製品の中で、ドイツからの完成品輸入品、国内CMO包装品について、立上げ準備を行う。 技術的な立場から日本国内での新製品立ち上げProjectに参画し、ドイツ・国内CMOと協力しながら準備を進める。 3. CMOにて発生する各種変更に伴う、承認書への記載内容変更案のReview 新製品の薬事申請書類のReview Basic purpose of the job* •Prepare for the initial production for the launch of new products (FG import or Japanese CMO packaging) providing
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,
Senior Specialist, PS Operational Excellence leads implementation of appropriate operation to ensure PV activities in compliance with GVP/GPSP/GCP regulation with collaboration with internal/external partners. The Senior Specialist, PS Operational Excellence is responsible for: o Develop and maintain
Basic purpose of the job The manager of RRL JP provides strong leadership to develop and implement regulatory strategy for the assigned products/projects as RRL JP, and exercises activities which include: An integral member of the
Basic purpose of the job Based on sound medical knowledge, this role defines the local Patient Safety & Pharmacovigilance (PSPV) strategy not aonly for the delegated asset (AT) but also other products as needed and ensures
We are Lightsource bp – and we’re on a mission to become a global leader in onshore renewables, anchored by our proven track record in solar development. For over a decade we’ve been actively working to
We are Lightsource bp – and we’re on a mission to become a global leader in onshore renewables, anchored by our proven track record in solar development. For over a decade we’ve been actively working to
Responsible for executing the following basic MSL tasks under the guidance of his/her superior and the support of a senior MSL. • Responsible for building trust relationship with Key Individuals (KIs) in their therapeutic area and
Develop sales revenue/opex budgets, sales and marketing strategies and forecasts for PV system. Implement business strategies and initiatives of sales channel management and consolidation Responsible for the management and execution of assigned projects, including interfacing with other
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)
Enphase Energy is a global energy technology company and leading provider of solar, battery, and electric vehicle charging products. Founded in 2006, Enphase transformed the solar industry with our revolutionary microinverter technology, which turns sunlight into
Tenstorrent is leading the industry on cutting-edge AI technology, revolutionizing performance expectations, ease of use, and cost efficiency. With AI redefining the computing paradigm, solutions must evolve to unify innovations in software models, compilers, platforms, networking,
Job Overview Provide project related assistance for all assigned project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality
General Information Job Advert Title: Senior Manager, Technology and Data QA Location: Nihonbashi, Tokyo Division: Quality Assurance Employment Class: Permanent Description 【Purpose & Scope】 Responsible for managing and executing the Technology and Data Quality Assurance (TDQA)audit
PV専門家として、製薬業界でのパートナーシップやリーダーシップに焦点を当てた業務を担当します。医療専門家との緊密な連携を通じて、製品の安全性と有効性のマネジメントに貢献します。 企業情報 国内外で事業展開する製薬企業で、安全管理業務において豊富な実績を誇ります。医薬品の安全性確保に力を入れ、グローバル基準の品質保証体制を構築しています。 職務内容 * 市販後（GVP）および治験（GCP）で収集した有害事象の評価・規制当局への報告 * 国内外のグループ会社・提携会社との安全性情報交換 * 国内外の安全管理体制の構築および運用 * グローバル治験における安全管理体制の構築・実施 理想の人材 * 製薬企業での安全管理業務（GVP/GCP）ご経験が３年以上ある方 * CIOMS作成や海外企業との安全管理業務経験 条件・待遇 * 各種社会保険 * 産休・育休制度 * 資格取得サポート To apply online please click the Apply button below. For a confidential discussion
About us BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse
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.
A PV Sr Specialist role is open for an independent who can handle a variety of tasks related to pharmacovigilance in clinical trials. 企業情報 The employer is a small organization in the life science industry that conducts
Responsible for executing the following basic MSL tasks under the guidance of his/her superior and the support of a senior MSL. • Responsible for building trust relationship with Key Individuals (KIs) in their therapeutic area and
POSITION SUMMARY MSL Responsible for executing the following basic MSL tasks under the guidance of his/her superior and the support of a senior MSL. • Responsible for building trust relationship with Key Individuals (KIs) in their
