Johnson & Johnson is the worlds most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in pharmaceutical, and medical devices and
Work Schedule Other Environmental Conditions Office Job Description When you’re part of the team, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe.
Work Schedule Other Environmental Conditions Office Job Description 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(被監査部門への監査の実施、報告書作成保管等 1回/年) ・GVP対応(情報収集、当局報告、記録書作成保管等) ・薬事トレーニングの実施管理(年間計画の立案、トレーニング資料作成、e-learning等での実施、記録書作成保管等) ・プロモーションマテリアルレビューの管理 ・海外拠点及び顧客からの問合せ対応 必要とされる資格・経験 ・医薬品、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) ・薬事規制(特に安全管理業務)に関する知識 ・当局対応経験 ・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QMS適合性調査・ISO13485調査対応経験 ・安全性に関わる業務経験 ・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 Thermo Fisher Scientific Inc. is
At Elanco (NYCE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and
職務 概要 Position Summary : Responsible for providing execution system and its design, qualification, maintenance and administration at our Fuji Plant. 法規制の順守に関する責任 Regulatory Compliance Responsibilities: Ø GMP/GCTP, Japanese law and regulation. Ø IAPP 主な職務及び主な責任 Major Job Duties
Dimensions Directly reports to Tax Manager Work closely with Business Unit Finance (BUF) in one of three sectors (MedTech, Innovative Medicine and Vision Care), Local/Regional Global Services (GS), Business Support Center of Excellence (BS CoE) and
Description Who We Are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including Dr.Ci:Labo®, NEUTROGENA®, AVEENO®,
( 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
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
The Marketing Senior Director will be a member of the Biosense Japan Commercial Leadership Team. You will have direct responsibility for driving marketing strategies and key initiatives for Biosense Webster to profitably achieve the Japan commercial
Leads and implements the Health Care Compliance (HCC) program locally under supervision of the HCC Officer of MedTech Japan to ensure business practices and activities follow related J&J internal guidelines, local laws and regulations and anti-corruption
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
POSITION SUMMARY • Responsible to develop the Medical Affairs product strategy through the analysis of medical needs collected from all internal & external stakeholders of the therapeutic area • Responsible for leading MAF studies / publications
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
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,
Johnson & Johnson Innovative Medicine (JJIM) is recruiting for a(n) Quality Control Senior analyst, located in Janssen Fuji Site, Japan. This position is responsible for leading analytical method transfer for NPI to implement in country test.
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
SCOPE OF THE ROLE AND BASIC PURPOSE Responsible for overall quality and compliance action such as complaint handling, field action, change control and so on in Japan market for DePuy Synthes Joint Digital Biomaterial and Spine
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