求人一覧

マネジャーの最小の指導の下、薬機法全般に精通し、豊富な知識と経験を有し、円滑な薬事申請及び関連業務の遂行を目的とする。 【主な業務】 当社が製造販売する医療機器に係る下記を中心とした薬事申請業務の適切な履行を職責とする。 ○製造販売承認／認証申請、届出（計画立案、資料取集、PMDA／NB 照会対応） ○承認／認証の維持管理業務（変更管理、定期更新） ○QMS適合性調査申請 ○保険収載業務（保険適用希望書作成等） ○上記に係る一連の業務： ・製品に応じた薬事戦略の策定 ・設計製造所からの資料入手、必要に応じて追加試験の立案 ・MHLW/PMDA/NBとの照会回答、相談実施 ・変更管理の評価 ・販促物の確認

製品に係る下記を中心とした品質保証業務の適切な履行を職責とする。 ○医薬品医療機器等法ならびに QMS 省令を遵守した業務 ○品質情報に係る受付処理業務及び顧客対応 ○ISO13485:2003 要求事項の順守と維持管理 ○外国製造業者への製品品質の維持・改善の積極的な働きかけ ○製品回収・改修が必要となった場合、実施の推進（社内調整、行政とのコミュニケーション） ○薬務渉外（PMDA ・都庁対応） ○外国製造業者登録・QMS 適合性調査に係る業務 ○業態の維持管理に係る業務 ○QMS 省令遵守の仕組み構築、改善活動の実施、推進

○ Understand key competitors and their relative strengths/weaknesses ○ Understand customer groups, including why customers buy the product or service approach for the product or portfolio ○ Understand the different marketing channel strategies and associated business implications ○ Track and report results/KPIs to leadership and sales ○ Understand key competitors and their relative strengths/weaknesses and maintains networks of people and resources for obtaining competitive information ○ Explain different product features to different customers as appropriate to their needs ○ Maintain customer engagement and deeply understands customer needs ○ Play a role in developing key strategy documents: strategic plan, annual marketing plan, product launch plans, etc ○ Support the creation of Project Charters, CERs, and Business Case Financial Models as applicable ○ Understand competitive dynamics in the market ○ Understand what customers value and how they perceive different attributes of the product or portfolio ○ Articulate why the product or portfolio adds value or solves problems for the customer ○ Create marketing strategies to understand, develop, and enhance the relationship between the customer and the product or portfolio ○ Propose objectives for generating clinical evidence and evaluates studies ○ Tie the business goal of the product or portfolio to the overall goal of Stryker ○ Synthesize market trends and make recommendations on areas of strategic focus ○ Develop new strategies, sales tools, and communication plans for the product or portfolio ○ Apply clinical knowledge in combination with technical knowledge to educate and articulate value ○ Work closely with sales training/sales enablement to set the sales training strategy for the product or portfolio ○ Responsible for the obsolescence plan ○ Provide analytical support to set price ○ Articulate desired communications outcomes consistent with marketing strategy to MarComm team ○ Establish short-range and long-range improvement goals for the product management team, and under guidance, develop action plans to achieve those goals ○ Analyze customer satisfaction to assess trends in customer engagement, and incorporates trends into strategic planning ○ Provide marketing intelligence group with key objectives and inputs to drive customer insights

脳血管内インターベンション関連製品の営業活動全般 ○医療機関（大学病院、 国公立病院等）を訪問し、医療従事者（主に医師）に対して 　製品の提案、特徴や使用方法の説明、安全・適正使用に関する情報提供 ○医療現場の現状やニーズの情報収集 ○製品使用時の手術や検査の立会い（製品の適正使用のサポート） ○医療従事者向けの勉強会やセミナーの企画、実施 ○販売代理店への営業サポート、製品勉強会の実施、販売促進活動