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,
Job Description Outbound managerとしてチームのリードをお任せします。倉庫オペレーション業務経験のある方、治験ビジネスにご興味のある方、将来的にキャリアを広げる方向性に興味のある方、英語を使った仕事に挑戦したい方など、ご応募をお待ち申し上げます。 Division Specific Information Clinical Trials Division (CTD) partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time
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
Job Description About This Role This role is serving as IT focal point for Japan R&D, acting as IT Business Analyst, affiliate level of IT project manager and supporting Japan R&D members for any kinds of
Job Description Summary ・ 開発品の添付文書案の作成 ・ 市販後における添付文書改訂対応 ・ eCTD publishing、申請電子データ提出の日本対応 ・ 承認内容等のデータベース管理 Job Description 先発医薬品の添付文書情報を注意深く監視し、改訂情報等入手した場合には速やかにその内容を自社品添付文書に反映させる（後発医薬品） CDS（Core Data Sheet）更新等の添付文書改訂案件が発生した場合には、安全性部門と協力し適切なタイミングで添付文書改訂を検討・実施する（先発医薬品相当） 開発品において開発薬事等関連部署と協力し、添付文書記載要領に準拠しかつ、先発医薬品の記載内容を参考に添付文書案を作成する 添付文書案作成や市販後の添付文書改訂において、必要に応じて規制当局（MHLW/PMDA）とコミュニケーションを図る 添付文書の記載内容や法定表示事項を参考に、テキストマスターの作成・承認やアートワークレビューを実施する eCTD、申請電子データのPMDA仕様を把握し、日本での提出をリードする 海外のオペレーションチームと連携し、日本仕様のeCTD、申請電子データの編纂をコントロールする 承認書管理データベース等ITインフラの運用管理を行う 【必須要件】 グローバルと英語でコミュニケーションを主体的に実施できる 以下のa)またはｂ）の条件を満たす a)添付文書業務の経験がある a)添付文書関連通知の知識を有する b)eCTD、申請電子データ関連業務の経験を有する 【望ましい資格】薬剤師資格 【求める人材】 プロジェクトに応じてリーダーおよびサポーターとなり、周囲と連携して 業務遂行できる ラーニングアジリティ 計画的に業務の遂行ができる
Title: Operations Associate Job Purpose: Ensure the efficient use of packaging and supplies available in the warehouse to satisfy client and internal requirements. Main Duties and Responsibilities: Ensure that all shipments recovered are arrived webscan at
Do you have a strong background in non-clinical activities? We are looking for a Non-Clinical Expert to join our team at Novo Nordisk. If you are ready to contribute to the development, submission, and approval of new drugs/devices,
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
Are you looking for your next “great mission” professionally? Do you feel like you have more to give, want to learn new skills and be part of a team with a rewarding mission supporting our Active-Duty
The Leidos Military & Veterans Health Solutions Group is sourcing candidates (both counselors and supervisors) for our PACAF Adolescent Support and Counseling Services (ASACS) program. This program implements a community-based adolescent support and counseling program for
Job Description Summary Uses quality knowledge combined with skills in Product Surveillance to handle complaints, support regulatory reporting, and establish appropriate corrective and preventive actions for the safe and effective use of GE HealthCare Ultrasound products.
The Leidos Military & Veterans Health Solutions Group is hiring a counselor for our PACAF and Marines Adolescent Support and Counseling Services (ASACS) program. This program implements a community-based adolescent support and counseling program for the
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on
JOB DESCRIPTION: Primary Function Abbott Medical Japan is seeking a dedicated and ambitious Clinical Study Specialist (CRA) to join our team. This mid-level position in Clinical Research is ideal for those aspiring to start or advance their career
Job Overview At a global level, drive Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines to develop the informed consent form (ICF), including
Are you looking for your next “great mission” professionally? Do you feel like you have more to give, want to learn new skills and be part of a team with a rewarding mission supporting our Active-Duty
Are you looking for your next “great mission” professionally? Do you feel like you have more to give, want to learn new skills and be part of a team with a rewarding mission supporting our Active-Duty
Department: GQP Compliance Group Report to: Head of Quality Japan General This role is to serve as an expert in the key quality management system for Japan subsidiary with regards to GxP requirements as well as
Are you looking for your next “great mission” professionally? Do you feel like you have more to give, want to learn new skills and be part of a team with a rewarding mission supporting our Active-Duty
