Tokyo,12.0M ～ 15.0M

Purpose:

Establish medical affairs as strategic partner to business by developing therapy area strategic goals and execution plans in active partnership with local, regional and global marketing and medical to support yearly and long term plans for business strategy and goals To ensure compliance for all medical affairs related activities with ethics and integrity Building & enhancing the scientific image of the company (internal & external).

Job Specifications:

Key Responsibility:

KOL and professional society Management: Develop, nurture and engage KOLs and professional scientific societies in scientific exchange activities that differentiate the company as a scientifically driven healthcare organization. Represent the company's medical affairs to external stake holders. Medical Affairs Strategy & Implementation: Develop Medical affairs strategy related to pre-launch, launch and post launch activities: conceptualize and implement Medical plan in unison with commercial strategy) to support improving patient outcomes
? Establish evidence generation plan in close collaboration with various stakeholders towards conduct of clinical studies to generate scientific data supporting the company's therapy areas of interest
? Develop High Impact Clinical education( non-promotional education) and voice of customer( advisory boards) initiatives in close collaboration with National societies
? Work closely in a cross-functional approach with the therapy unit to identify the unmet needs and bring voice of customer to the table cultivating innovation ? medical advisory boards
? Develop Digital education initiatives: webinars, digital education contents on therapy
Cross functional insights & support:
? With marketing team: Design/provide medical insights for the Marketing team and strategize dissemination of therapy-related communication to support brand management
? With regional teams: Effectively interface with the regional and global team to ensure optimal implementation of regional & global initiatives.
? With Market access teams: Effectively interface with market access to provide subject matter expertise that enables resolution of market access and funding issues. This includes working closely with the Market Access team in designing and implementing the HEOR studies/data.
? With commercial excellence: Therapy training to commercial team
? With business development team: provides insights towards medical due diligence activities
Compliance:
? Review of promotional material & material for submission to regulatory authorities
Provide therapy training to the commercial colleagues

Tokyo,12.0M ～ 16.0M

- Responsible for leading the relevant Japan development team (called ‘Japan Evidence Generation Team’, JEGT), and developing an integrated Japan development plan incorporating local current medical/clinical insights into specific molecules in accordance with global development strategy.
- Contribute medical/clinical expertise to advancing our pipeline Responsibilities include,
- As the lead of the JEGT, appropriately share Global EGT strategies to the JEGT members, indicate strategic direction of JEGT in accordance with global strategy and ensure that Japan product strategies are based on multifaceted considerations aiming to maximize values for patients and Amgen.
- As the lead of JEGT, encourage active and efficient work styles in accordance with the Team Charter and build an environment where each member can utilize their full potential
- Provide deep local medical/clinical and scientific (as applicable) insights to local and global product teams
- Partner with Regulatory Affairs to facilitate local registration by providing medical/scientific leadership and input into key regulatory deliverables, i.e. CTD, Regulatory responses, etc.
- Partner with study teams and operation teams to ensure timely study delivery.
- Support the Medical Affairs in capturing and translating local data gaps into actionable evidence generation plans (EGPs), in alignment with global product strategy and global EGP.
- As the clinical expert on the product, communicate the total evidence and biologic insights with internal stakeholders to align and inform their strategies, and with external stakeholders (KOLs / investigators, regulators, and payers) to shape the practice of medicine

Tokyo,Osaka,15.0M ～ 20.0M

■職務概要
臨床開発プロジェクトの進捗・品質・予算等を総合的に管理するプロジェクトマネジメント業務

・臨床開発プロジェクトのタイムラインの管理
・プロジェクトに関する提案、契約締結
・社内の調整・進捗管理（主に、プロジェクトメンバーとなるCTL、CRAなど）
・プロジェクトの予算管理・調整
・リスクマネジメントプランの作成
・開発戦略提案、ビッドへの参画、契約締結に向けた交渉
・開発他部門との調整、進捗管理
・グローバル治験・アジア治験においては、日本発信のプロジェクトをマネジメント
・他国CPMとの協業


Project management duties to comprehensively manage the progress, quality, budget, etc. of clinical development projects

- Management of timelines for clinical development projects
- Suggestions and contract conclusions regarding projects
- Internal coordination and progress management (mainly for projects) Members such as CTL and CRA)
- Project budget management/coordination
- Preparation of risk management plan
- Proposal of development strategy, participation in bids, negotiations for contract conclusion
- Coordination with other development departments, Progress management
- Global clinical trials・Management of projects originating in Japan in Asian clinical trials
- Collaboration with Clinical Project Managers from other countries