e-医療機器　転職・仕事・業界　完全ガイド

・Closely communicating with R&D, under the allowed contract, encourage and support
partnering Dx company in getting P&R (Pricing and Reimbursement) with optimal amount
and timing
・Develop contingency P&R strategy for a case such as drug use outside an approved
method/panel, Prescription in an account outside the government s specification

・Conduct Dx related market research and analysis, while sharing business insights
・Aligning with Medical Affairs, Business Units , Market Access, R&D and global team, lead
strategic development and agreement for: relationship building with precision-medicine KOL;
advocacy of target mutation; action to guideline inclusion; sales education planning; action to
detailed issues in operating testing (limited to points where PharmaCo can intervene)
・Actively meet, communicate with, and support partnering Dx company and external
stakeholders to achieve strategic objective, while working with internal stakeholders
・Track pre-defined KPIs and improve execution, while mobilizing internal stakeholders

・海外臨床試験成績を用いた承認申請業務
－承認申請資料の作成
－海外臨床試験のQC業務（GCP適合性確認業務）を含めた
プロジェクト全体のリード

*スペシャリスト～マネージャー（部下なし）レベルを想定。
スペシャリストレベルの方の場合は、上記業務のサポートからスタートしていただきます。
*Report to 臨床開発マネージャー

・社内外の関係者（社内：治験モニター他　社外：治験施設の医師他）に対する製品、手技のトレーニングを行う
・トレーニングに必要な資料を作成する

＜補足＞
・医療機関でのトレーニング、ワークショップのため、外出や出張、休日出勤あり

Your responsibilities include:
1. Project/Program Management: Develops and implements project plan, including cost, schedule, risk and performance for new product introduction, continuation or acquisition integration; Builds team ownership and commitment to project plans; Provides structured thinking to project team on overall approach and delegates as appropriate; Directs and trains key project management processes.; a focus on the Four Voices, personal accountability, and a commitment to results; Leads the team in appropriate decision making through strong judgment and the ability to analyze options and implications.

2. Communications and Reviews:Responsible for team and cross-functional level communications; Will act as liaison between the team and the business; Participates in program phase reviews; defines and tracks key business unit metrics; Responsible for elevating critical business risks on programs to the business and/or functional managers.

3. Relationship/People Management: Provides input to functional Managers/Directors on team and team member performance; Develops and maintains strong relationships with functional heads to drive success of Core Team members and overall Core Team contributions; Influences cross-functional collaboration.

4. Product/Technology Management: Directs and/or provides input to the technical approach to technology application and new product development; Identifies, communicates, and manages project risk.

5. Process Management: PDP/TDP system knowledge through delivery of high quality and high impact deliverables; Knowledge of quality system use for the creation and continued compliance of products; Actively reviews policy and practice improvements to drive functional excellence; Influences cross-functional systems effectiveness; Financial management - budget, forecast, and strategic plan input and preparation.