医療機器・医療品関連/東京23区の転職求人一覧

臨床薬理部は、企画推進グループとPKMSグループからなり、グローバルな視点での医薬品の早期開発意思決定、用法用量の最適化のために、研究本部を含め関連部門との密接な連携の下、初期臨床開発戦略・臨床試験計画の立案・実施、および薬物動態解析，モデリング&シミュレーション業務（M&S）を行います。本職においてはグローバルプロジェクトチームの日本PKMS担当としてM&S業務および薬物動態解析を遂行いただきます。

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

▼業務内容・プロジェクトマネジメント・仮説検証と課題発見・プロダクト・機能の改善施策立案、仕様策定　他

治験実施医療機関におけるモニタリング全般活動治験スタッフとの良好なコミュニケーション活動・治験契約締結交渉・初回IRB申請手続き・施設セットアップ、医療関係者トレーニングの実施・症例登録促進活動の実施、GCP・SOPに基づくモニタリング・治験の質的管理、原資料等の直接閲覧/症例報告書のSDV実施・施設における治験費用の管理

The primary purpose of this role is to provide a diverse range of contract support activities, related to contract processing. For example, it includes:-Preparing initial drafts of contracts based on the Company’s templates-Providing first-line reviews of various contracts of varying complexity with minimal supervision, in accordance with established negotiation parameters and guidance from Japan's Head of Legal...and more!

One of the Top International Medical device companies: Legal & Compliance Manager-Identify key legal issues and provide general legal advice to the business-Draft, review and amend legal agreements-Manage litigation with external counsel

・会社法や金商法、東証ルール、コーポレートガバナンスに基づく、決算取纏めと外部報告・会計方針及び決算方針の立案、IFRSを活用した財務管理の強化と管理精度の向上・会計ガバナンス体制の構築、会計処理の指導

• 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

JPN IT/AI Medical venture company: Legal -General corporate legal -Negotiate alliances with other corporate inside/outside Japan-Support launching products internationally-Support internal legal related issues-Support M&A-Handle legal matters when facilitating board/stakeholders meetings