Description Kenvue is currently recruiting a PR Specialist. This position reports into Senior Manager, External Communications, and is based in Tokyo, Japan. Who We Are At Kenvue, we realize the extraordinary power of everyday care. Built
職務 概要 Position Summary : 富士 New Product Introduction(NPI)/Packaging Specialist ( Project Management /Engineering )は以下職務を行う。 The New Product Introduction(NPI)/Packaging Specialist ( Project Management /Engineering ) for as follow l 富士工場新製品導入のガバナンス,プロジェクトの実施 Execute governance and project for Fuji
( 概要 ) 日本国内で治験を実施するためのオペレーションチームリーダーとして,国内外のステークホルダーとの協議•交渉など,エキスパートとしてのコミュニケーションを通じ,品質を確保した臨床試験を計画通りに遂行する。 ( 具体的な業務例 ) •試験実施施設の選定戦略,症例組み入れプラン•戦略の作成及び実行 •試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 •試験全体の進捗および GCP , SOP に沿った臨床試験の実施と品質の確保 •国際共同試験の場合,海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション •試験における Risk & Issue Management •治験契約締結交渉,データ固定, GCP • SOP に基づくモニタリングに対するモニターへのフォロー •チームビルディング,ステークホルダーマネジメントによるチーム作り •社内の改善活動 / Task force team への参加 •試験全体の予算の管理 Position Summary: The
Description Kenvue is currently recruiting for: Legal Counsel This position reports into Legal Director Consumer Health Korea and is based at Ebisu, Tokyo, Japan. Who We Are At Kenvue, we realize the extraordinary power of everyday
Position Summary: The TA Functional Manager(FM) is accountable for strategic and operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines
The HCCO plays a crucial role in helping Johnson & Johnson (J&J) to achieve high performance with high integrity: Leading the HCC Program for J&J MedTech and Vision Japan, to ensure business practices and activities are
POSITION SUMMARY •Responsible for leading the MSL group activities. •Support for HCPs through timely dissemination of emerging scientific and medical information from amultitude of sources. •Analyze and identify key MSL insights, and provide to the DA
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
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
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
SUMMARY Responsible and accountable for Medical Affairs strategy of Urological cancer products C ollaborates with internal and external stakeholders including key opinion leaders to develop and implement the overall M edical Affairs strategy for product lifecycle align ed
Key Responsibilities: • Execute action related regulatory compliance by having preventive and avoidance action doing risk analysis and management in RA part. • Take action to inquiry and/or instruction from Health Authority as a representative from Business
Job Description Job title: RA Specialist 職務内容: 医療機器、体外診断用医薬品、動物用医薬品、研究用試薬（消耗品、機器含む）に係る薬事対応業務 ・製造販売業の維持・管理（更新申請手続き等、3役会議事務局運営など） ・販売店が保有する高度医療機器販売業・貸与業、医薬品販売業、動物用医薬品卸売販売業の管理 ・QMS適合性調査申請（承認前調査/定期調査） ・外国製造業者認定・登録の維持・管理 ・QMS内部監査対応 ・プロモーションマテリアルレビューの管理 ・社内および顧客からの要求における資料提供等のサポート業務 ・製品関連証明書対応 *（COA/COO/COS/COI/Animal origin statement/BSE,TSE free statement他） ・海外拠点及および顧客への問合せ対応 ・再生医療等製品材料適格性相談の確認書の提供管理 ・MF申請及び関連対応業務（PMDA及び顧客） 必要とされる資格・経験 ・医療品、医療機器又は体外診断用医薬品分野におけるRAQAでの業務経験（1年以上） ・薬機法およびQMS関連規制に関する知識 ・海外とコミュニケーションを行う英語力（メール対応） ・基本的なPCスキル（Word、Excel（表計算・グラフ作成）、PowerPoint） 歓迎される資格・経験 ・規制当局又は認証登録機関によるISO13485調査対応経験 ・ドキュメント管理システムの使用経験 ・製造販売業の三役の経験 *Certification of Analysis/Certification
Job Description Job Summary: To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services (FCS) approved procedures and policies, cGMP, cGDP, and regulatory requirements. Maintain the FCS Japan Quality System in compliance
Job Description When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected,
Job Description Job Responsibilities: Develop and execute strategies that align with the global business units’ strategy. Focus business areas products include ImmunoDiagnostics and Molecular Diagnostics. and other areas may be added as appropriate. Identify and evaluate
