e-医療機器　転職・仕事・業界　完全ガイド

・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.