薬事、メディカルライティングの転職求人一覧

品質と信頼の担い手として、グローバル医薬品の発展に貢献できるポジションです。【ご紹介する企業について】革新的なバイオ医薬品の提供を通じ、世界中の医療の発展に貢献することを目指しています。患者中心の視点を大切にし、品質と信頼性を重視するグローバル企業の日本法人として、医薬品の開発と普及に尽力しています。国際的なネットワークと先進的な知見を活かし、医療現場での信頼を築いています。【ポジション概要】 薬事申請や品質保証業務において、医薬品の申請や当局対応を担当します。プロジェクトごとに担当を持ち、社内外の関係者と協力して医薬品の品質と信頼性を支えます。【業務内容】・医薬品の薬事申請、当局対応（申請・変更届の準備と提出）・CTD・FD申請書類の作成、確認、関係者との連携調整・新製品導入プロジェクトにおける薬事・品質保証業務の支援・薬事関連の当局相談対応・CMCに関する薬事支援・製造業者との交渉、調整を行い、承認内容と製造方法の一貫性を維持医薬品申請に携わりながら、品質保証ポジションに携わりませんか。興味がありましたらご応募ください。#LI-Onsite

■ About the CompanyOur client is the Japan subsidiary of a global healthcare company that aims to improve health and enhance the quality of medical care through innovative pharmaceutical and nutrition products. The company is committed to innovation and sustainable growth, with a corporate culture that emphasizes cutting-edge scientific solutions and a focus on continuous improvement.■ Summary of the PositionIn this role, you will oversee all regulatory activities related to pharmaceuticals and nutrition products, ensuring compliance with marketing authorization requirements and maintaining product approvals. You will lead the regulatory strategy for nutrition products, drive key projects, and liaise with regulatory authorities. Additionally, you will manage quality and safety operations in line with Japan's regulatory standards, ensuring the successful commercialization and life-cycle management of the company’s products.■ Key Responsibilit

<職務内容>薬事申請スペシャリストを募集します。（スペシャリスト…ラインマネジメントを行わない代わりに高い専門性をもって業務を推進・遂行する役職のこと）国内薬事業務における申請業務・業態管理・当局との折衝や関連団体の窓口となっていただきます。海外地域を含む全般の薬事申請にも関わって頂き、幅広い経験を積むことも可能です。【主な担当業務】・体外診断用医薬品・医療機器の薬事申請業務（～classⅢ）・他部門や若手社員への薬事関連法規の教育・指導・業許可関連登録管理業務・薬事関連規制情報収集・その他法規制対応※R&Dの中の薬事対応部署ですのでQMS組織として品質記録の取り回しも行います。

Job PurposeThe purpose of this role is to develop and execute effective pricing strategies for new and existing pharmaceutical products, ensuring alignment with business objectives and regulatory requirements. The individual will lead cross-functional teams, negotiate with the Ministry of Health, Labour and Welfare (MHLW), and collaborate with the Asia Pacific market access team to optimize pricing outcomes and contribute to industry discussions.Key Responsibilities・Develop pricing strategy for responsible products.・Lead cross-functional team in material development for New Drug Price Application and negotiate with MHLW.・Calculate expected new drug prices for BP/LRFP/BD/R&D decision-making.・Conduct regular calculations, assumptions, and assessments of price revisions, repricing, and PMP returns.・Participate in JCST and cross-functional teams to provide pricing input to achieve target prices.・Align with AP market access team on Japan's pricin

Responsible for planning and executing medical activities and make sure timely and effective execution aligned to medical strategy. Reporting to TA Medical head1. Key accountabilities1-1. Lead Medical Strategy■ Lead and monitor the execution of the Japan Medical Plan to ensure on-time and on-budget delivery of all tactical activities or deliverables■ Provide medical and technical input into medically accurate development of Brand promotional materials in close alignment with marketing team and communicate the details and progress of the Medical Plan to local Medical Team, the Global Medical and all parties responsible for execution■ Work with cross-functional, multidisciplinary teams to facilitate the creation of medical strategies about products to answer unsolicited medical requests from internal and external stakeholders and ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medic

【主な担当業務】・体外診断用医薬品・医療機器の薬事申請業務・業許可関連登録管理業務・薬事関連規制情報収集・その他法規制対応※R&Dの中の薬事対応部署ですのでQMS組織として品質記録の取り回しも行います。

リスクの高い製品（クラスⅢ）の臨床性能試験～薬事申請・保険適用までを担当するリーダーポジションの募集です。業務内容・臨床性能試験のプロトコル・SOP作成、試験の運営、報告書のとりまとめ・規制要求事項の開発部門へのインプット、性能試験計画や結果のレビュー、申請資料の作成、当局対応・保険適用希望書の作成、当局対応

迅速な承認取得を目指し開発薬事職として下記業務を担当します。・開発薬事戦略の立案・CTD作成・PMDAとの折衝

• Serving as a contact point for the company, coordinates for pharmaceutical affairs matters on product development between internal concerned departments and regulatory authority.• Performs pharmaceutical regulatory affairs tasks for obtaining pharmaceutical product approval.• Prepares various pharmaceutical regulatory affairs documents in a timely and appropriate manner according to the product development plan.• Manages pharmaceutical regulatory affairs schedules for product development plan.• Working with internal concerned departments, prepares appendices attached to pharmaceutical regulatory affairs documents to be submitted to regulatory authority and submits them.• Negotiates with subcontractors and external parties about pharmaceutical affairs issues as needed.• Working collaboratively with other departments, reviews the documents (minutes, examination report, etc.) created by regulatory authority, builds a consensus and confirm the