Tokyo オリンパス株式会社 ¥6,000,000 - ¥8,000,000 per year
【オリンパスについて】
オリンパスは「私たちの存在意義」として掲げる、世界の人々の健康と安心、心の豊かさの実現を目指しています。世界をリードするメドテックカンパニーとして、私たちは医療従事者の方々と共に、病変の早期発見、診断、そして低侵襲治療に役立つ革新的なソリューション・サービスの提供を通じて対象疾患における医療水準の向上に貢献してまいります。
創業から100余年、オリンパスはこれからも世界中のお客様に最適な価値をもたらす製品を提供することで、社会への貢献を目指します。
5つのコアバリュー「Patient Focus(患者さん第一)、Innovation(イノベーション)、Impact(実行実現)、Empathy(共感)、Integrity(誠実)」は私たちの存在意義を全うするものです。
これらは、私たちの行動、意思決定、部門や組織全体の道しるべとなります。
5つのコアバリューが日々の仕事に向き合う上での基礎となり「世界の人々の健康と安心、心の豊かさの実現」という私たちの存在意義を実現し続けることができるのです。

【組織について】
オリンパスのMedical & Scientific Affairs部門は、医学的、科学的、専門的能力を活用し、臨床的に適切で経済的に価値のある、安全で効果的な製品を世界中に提供することによって、事業と患者さんに貢献します。
臨床・医療分野の専門知識を医療従事者に提供することによって、高い価値の創出と持続的成長を実現しながら、医療の水準を向上させることで、患者さんの予後の改善を目指しています。

【業務内容】
臨床評価計画書および臨床評価報告書の作成業務です。
弊社製品に関連する医学論文等を調査し、安全性や有効性の評価と文書作成を主とした業務です。製品開発や市販後の活動にも深く関連しています。また、認証機関の監査対応なども行います。

具体的には以下のような業務を担当していただきます。
・新製品開発テーマへ参画し、臨床評価観点で臨床データのGAP分析を実施し、臨床評価報告書を作成する
・市販後製品に対し、文献や安全情報など臨床データの収集・分析を実施し、臨床評価報告書を作成する
・関連社内標準の維持・改善活動
・第三者認証機関の監査対応

(変更の範囲 / Scope of change)
会社の定める業務
Business as defined by the company

【ポジションの魅力】
取り扱う製品の分野が幅広く、多数の報告書に携わりながら、経験を積むことができます。また、グローバル組織の一員として働くことできます。

【採用背景】
増員

【必須要件】
・学歴:学部卒以上
・英語:英文文献や英文文書の読解できるレベル・経験がある
・文献検索業務の経験 (例. Pubmed, Embaseなど)
・医療業界における法規制の経験*か、医療機器の開発の経験がある方
(医療機器メーカー、製薬メーカー、CROなど)
※法規制の経験は具体的に以下の業務経験となります。
・医療機器もしくは製薬メーカーにおける、Regulatory Affairs(製品登録、薬事業務)の経験 (米国FDA、日本PMDA、中国MPA、欧州MDRなど)
・医療機器もしくは製薬メーカーにおける、規制要求事項やガイダンスの分析、展開の経験

【歓迎要件】
・医療従事経験者
・臨床評価報告書作成業務の経験

【求める人物像】
・Patient focus : 患者さんの安全や内視鏡医療を優先した行動・考え方ができる方
・Innovation:先入観にとらわれず、新しいことにチャレンジすることができる方
・Impact :主体的に業務を勧め、組織や地域の壁を越えて連携した活動ができる方
・Empathy:多様な意見を取り入れ、より大きな成果に向けた行動ができる方
・Integrity:自らの活動において、透明性・公平性を持って行動できる方

【雇用形態】
正社員(試用期間3ヶ月:待遇の変更はなし)

【勤務時間】
8:45~17:30 (休憩:昼45分)
標準労働時間8時間

※フレックスタイム制度あり/コアタイム無し(管理職採用の場合対象外)
※時短勤務制度あり
※テレワーク勤務あり・時間外労働あり

〈ご参考〉業務の状況等により変更となる可能性がございます
・在宅勤務:週3-4日程度

【休暇・休日】
・休日 :土日祝、年末年始、GW、夏期休暇
・年間休日:129日(自社カレンダーに応ず)
・有給休暇:20日間の年次有給休暇を付与。
※入社初年度は入社月にて変動します(最大20日)
※時間単位での取得も可能です(一部条件有)

※その他待遇/制度については以下をご覧ください。

Show more Show less

  • Tokyo ICON plc ¥6,000,000 - ¥9,000,000 per year

    · We're proud to foster an inclusive environment driving innovation and excellence, · a Pharmacovigilance Reporting Associate is responsible for the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities. ...


  • Chiyoda MSD Full time¥5,000,000 - ¥10,000,000 per year

    Contribute to the development of innovative new drugs for cancer treatment through collaboration with various departments. Develop and implement clinical trial plans, and work closely with internal and external stakeholders to achieve project goals. · Develop and implement clinic ...


  • Chiyoda MSD Full time¥5,000,000 - ¥15,000,000 per year

    We are seeking a Senior Clinical Scientist to join our Oncology Clinical Science team. The successful candidate will be responsible for developing and executing clinical trials, working closely with cross-functional teams, and collaborating with external experts. The ideal candid ...


  • Chiyoda MSD Full time¥5,000,000 - ¥10,000,000 per year

    We are seeking a highly skilled and experienced R&D Oncology Clinical Science Clinical Research Sr. Scientist to join our team. The successful candidate will be responsible for developing and implementing clinical research strategies, collaborating with cross-functional teams, an ...


  • Chiyoda MSD Full time¥5,000,000 - ¥10,000,000 per year

    We are seeking a Senior Clinical Scientist to join our Oncology Clinical Science team. The successful candidate will be responsible for leading clinical trials and developing strategies for the development of new oncology drugs. The role requires strong communication and collabor ...


  • Tokyo ICON plc Full time¥4,032,000 - ¥6,048,000 per year

    ICON plc is seeking a Pharmacovigilance Reporting Associate to join its diverse and dynamic team. · ...


  • Chiyoda MSD Full time¥8,000,000 - ¥16,000,000 per year

    We are seeking an Associate Principal Scientist to lead clinical development projects in infectious diseases and vaccines. The successful candidate will have experience in clinical trial operations, clinical study design, learning sciences, negotiation, strategic thinking. · ...


  • Chiyoda MSD Full time¥7,000,000 - ¥15,000,000 per year

    +We are seeking an R&D Clinical Research Infectious Diseases Associate Principal Scientist with clinical development experience in related fields to lead clinical development projects for infectious diseases and vaccines. · This individual will collaborate closely with internal/e ...


  • Minato Novartis

    We are seeking an Associate Clinical Sciences Trial Leader to lead or support global cross-functional clinical trial teams in the early clinical development stage (Phase 1 to Phase 2a). · Lead or support the creation of clinical trial implementation plans in collaboration with Me ...


  • Tokyo ICON Strategic Solutions ¥2,700,000 - ¥7,200,000 per year

    We are currently seeking a Senior Medical Writer to join our diverse and dynamic team at ICON plc. · We're proud to foster an inclusive environment driving innovation and excellence, · and we welcome you to join us on our mission to shape the future of clinical development. · ...

  • PK specialist

    6日前


    Tokyo SERVIER MONDE Full time¥1,000,000 - ¥1,300,000 per year

    Leveraging the latest insights in pharmacokinetics (PK) and pharmacodynamics (PD), we apply advanced kinetic analysis to drive efficient drug development, regulatory registration and maximize compound value. · ...


  • Tokyo GE HealthCare Full time¥600,000 - ¥1,200,000 per year

    Region Product Marketing Specialist role involves preparation of proposals/bids, contract negotiation, and commercial risk assessment. The role operates with some autonomy and is subject to regular review of sales results. · ...


  • Tokyo AvePoint ¥4,500,000 - ¥7,500,000 per year

    The Accounting Manager will provide support the company's accounting, financial reporting, accounting related research and market intel, and general accounting procedures. · Supporting in overseeing accounting operations including; Invoicing, AR, AP, Expense, Closing. Identifying ...


  • Minato Novartis ¥4,000,000 - ¥6,000,000 per year

    Clinical Research Associate monitors patient data and research-related information at clinical research sites and clinical trials. Investigator provides input to data validation plans in accordance with research protocols, regulatory requirements, and good clinical practices. Pro ...


  • Tokyo Parexel OTHER¥4,000,000 - ¥8,000,000 per year

    At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. · Each of us, no matter ...


  • Minato Novartis ¥2,500,000 - ¥5,000,000 per year

    Monitor patient data and research-related information for clinical research sites and clinical trials. Provide input to data validation plans and offer investigation-related information as needed from source documents, research records, and site visits. Monitor the selection of i ...


  • Akasaka, Tokyo GSK ¥9,000,000 - ¥12,000,000 per year

    Principal Safety Evaluation is responsible for ensuring the safety of products and patients throughout the product lifecycle. This includes conducting cross-functional activities to support the development of GSK Japan's projects, designing and implementing safety plans for clini ...

  • PK specialist

    6日前


    Tokyo Servier ¥900,000 - ¥1,200,000 per year

    Leveraging advanced kinetic analysis to drive efficient drug development · and maximize compound value. · ...


  • Tokyo HirePlanner Japan | Find Jobs in Japan, Work in Japan, Careers in Japan 🇯🇵 ¥2,000,000 - ¥2,500,000 per year

    We are seeking a highly skilled and detail-oriented Financial Analyst to join our Finance FP&A team. This role is responsible for providing strategic financial insights, developing financial models, and supporting budgeting and forecasting processes. The ideal candidate will have ...


  • Tokyo Medtronic Full time¥5,000,000 - ¥8,000,000 per year

    At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. · p苦情担当スペシャリスト · tough punishment specialist · safety management department member performing following duties: kakujou shori: customer complai ...

  • Safety Evaluation

    2ヶ月前


    Akasaka, Tokyo GSK

    Contribute to ensuring the safety of participants and patients through the evaluation and implementation of safety measures throughout the product lifecycle. · Plan and implement clinical trials to ensure the safety of participants and patients. · Develop and review application p ...