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
This is a contractor role untill End of Mar 2025 医薬品,医療機器等の品質,有効性及び安全性の確保等に関する法律(以下,薬機法) 及び関連法規に基 づく,医薬品,医薬部外品の薬事承認申請,⾏政対応,外国製造所との対応等の業務を,業務報告者の監督の下に行う 。 • 医薬品又は医薬部外品の薬事承認申請,届出 • 医薬品又は医薬部外品の変更管理業務(適切なRegulatory Assessmentの実施) • 外部講習会及び関連学会への参加等による薬事•業界知識の向上及び部内への伝達•理系大卒以上 • 5 年以上の CMC 薬事の経験。若しくは CMC 研究または生産部門で 5 年以上の業務経験と, CMC 申請資料作成の経験があり,薬事業務に興味と意欲がある。 •海外カウンターパート及び国内関係部門と連携して業務を遂行する調整能力がある。 •複数の製品の次々に発生する変更事項について,複数の国の変更申請を確実に履行するための,整理•計画•実行能力がある。 •業務上必要な英語の読み書きと会話ができ,さらに上達意欲がある。 ( 目安:
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
As a business partner facing role, the Business Analyst participates in strategic planning, business planning and analysis, needs analysis and business risk assessment and consults with business partners to shape demand and determine how to best
As a business partner facing role, the Business Analyst participates in strategic planning, business planning and analysis, needs analysis and business risk assessment and consults with business partners to shape demand and determine how to best
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
JOB Details) High Priority • Analyze policy environment changes and report those changes to Janssen internal stakeholders (Japan and global counterparts) • Work closely with J-CST( Japan Commercial Strategy Team) , BU marketing and IEGP(Integrated Evidence
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
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
Overall purpose of job: A member of the Inter-Regional Transport Excellence leadership team, the Manager IRTE is responsible for flawless operational execution of inter-region transport lanes; managed door-door. This includes day to day operational issue management,
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
