Jobs at Msd in Japan, Chiyoda

Job Description

• 開発戦略策定の補佐 （早期及び後期開発計画書への日本の臨床試験計画のインプット）
• 開発戦略に基づいた機構相談の立案や資料作成のサポート、及び照会事項に対する回答作成
• 治験実施計画書の立案及び翻訳・作成
  • ローカル試験（試験骨子から作成）
  • グローバル試験（主に翻訳）：米国本社や海外ベンダーへの説明、交渉を含む

• 同意説明文書（会社案）の作成
• 治験実施計画書に関連する資料（症例報告書、関連手順書等）の作成サポート及びレビュー
• 治験届（CTN）の添付書類作成とPMDAからの照会事項対応
• 症例の適格性確認、治験データに対するメディカルモニタリング、重篤な副作用（SAE）対応
• 治験総括報告書及び承認申請資料（CTD）臨床パートの作成 （メディカルライターと協働）及びレビュー
• 承認申請後の照会事項に対する回答作成、適合性調査対応
• 学会発表、論文作成及びそれらのサポート

• 医薬品臨床開発業務の経験（オンコロジー経験あれば尚可）
• 治験関連文書の作成経験（治験実施計画書の作成経験あれば尚可）
• 社内（国内・外）関連部門及び外部専門医との密接な協働作業のためのコミュニケーションスキル
• 英語力（TOEICスコア730点以上目安）

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

· 試験計画、開始準備、実行、終了に亘り、トライアルチームをリードする

· チームメンバーや各種ベンダーが行う業務が遅滞なく進行するよう取りまとめる

· 試験にかかるコスト、主要マイルストン、リスク等のマネジメントを行う

· CRA（CRO含む）の相談窓口として、施設レベルの課題を解決する

· 試験を通じた文書管理コンプライアンス、各施設におけるクオリティを担保する

・CRM、Study Manager 等のご経験3年以上、または、CROで Project Leader 等の経験3年以上

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

·試験計画、開始準備、実行、終了に亘り、トライアルチームをリードする

·チームメンバーや各種ベンダーが行う業務が遅滞なく進行するよう取りまとめる

·試験にかかるコスト、主要マイルストン、リスク等のマネジメントを行う

· CRA（CRO含む）の相談窓口として、施設レベルの課題を解決する

·試験を通じた文書管理コンプライアンス、各施設におけるクオリティを担保する

・CRM、Study Manager 等のご経験3年以上、または、CROで Project Leader 等の経験3年以上

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Associate Director, Strategy (Corporate Strategy/Commercial Strategy & Operation)

• Strategic Thinking:Visualizes the way forward, identifying opportunities that add value to the work, to the business and to our customers.
• Project Management:Develops project plan based on scope defined with key internal stakeholders, drives project collaborating with members across the business, escalates issues to relevant leaders and sponsors.
• Problem Solving:Gathers and analyzes data and effectively responds to new, complex or problematic situations; creates solutions that drive value for our company and our customers, incorporating innovative approaches where relevant.
• Business & Financial Acumen:Understands and intelligently applies economic, financial and industry data to make business decisions
• Effective Communication:Plans and delivers ideas and information to others in a clear and impactful manner at high level of engagement.

Role1.) Corporate Strategy Chapter: Enterprise Commercial Strategy

The Corporate strategy team is responsible for developing and supporting the realization of our company's long-term strategy by working collaboratively with senior leadership and colleagues across the enterprise, mainly locally but also globally.

• Be a thought partner to senior management across the enterprise as an independent presence.
• Develop our long-term strategy and plan as a Japan market, which includes assessment of current environment, defining key objectives, identifying success factors, and comprehending constraints related to the organizational challenges.
• Orchestrate the realization of our long-term strategy and plan, including profitability analysis, process redesign, operational efficiencies, growth strategy, strategic planning, data collection, qualitative analysis, etc.
• Drive annual / quarterly prioritization processes by digesting long-term strategy into mid-term strategy/immediate priorities and visualize company’s overall status and monitor the progress by managing KPIs

• Support various types of transformation and initiatives within the subsidiary - commercial-related topics and otherwise - and play a lead role in driving changes.
• Examples of previously supported projects include but not limited to agile transformation, go to market strategy, digital capability assessment, customer engagement vision building, demand planning automation, workplace vaccination, etc.

< Mandatory required skill>

• Fluent English proficiency required to drive discussions within a Japan-market context
• Japanese : High language proficiency in Japanese is required.

Role 2. ) Commercial Strategy and Operation Chapter: Oncology or Portfolio area

The Commercial Strategy and Operation Chapter will be responsible for leading commercial strategy development based on the knowledge and skills in forecasting, alliance and launch/Sales operational excellence, and providing the capability to take on complex operations, including negotiations with internal, global, and external partners.

• Managing the commercial forecasting process, including strategy development, profit planning and senior leader’s alignment in both local and global stakeholders.
• Crafting the short to long-term commercial excellence model, which includes environment assessment, structure design with profitability analysis by collaborating cross functional colleagues
• Driving the various type of sales excellence related projects to maximize the oncology sales activities.
• Leading/supporting high business impact ad-hoc projects including life cycle management, new launch strategy development and other business issues

• Pharmaceutical and healthcare industry experience is preferred but not mandatory.
• Project management experiences in wide-scaled and/or complex project
• 5+ years of experiences in consultancy firm

等級（Grade）は面接評価に基づいて協議を行い決定致します/The pathway level will be determined based on discussions conducted in accordance with the interview evaluation.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Major Responsibilities

The successful candidate’s responsibilities will include, but not be limited, to the following:

• Maintaining and performing local process for accounting, including sales accounting, fix asset/lease accounting, etc.
• Assisting in closing process and preparing financial statements in both USGAAP and statutory.
• Dealing with internal and external audits by providing requested documents and explanations.
• Assisting in the preparation of accurate tax provision, tax returns and tax planning.
• Providing accounting & tax advice and guidance during the implementation of new business models or new software systems. Collaborating with cross-functional teams to assess the impact on financial processes, data migration, and reporting requirements, and making recommendations to ensure compliance and accuracy.

, Preferred Experience & Skills

• Strong knowledge of accounting, tax compliance, preferably experience in a corporate or public accounting environment.
• Proficiently using accounting software to enter and process financial transactions, generate reports, and maintain accurate financial records.
• Strong communication and interpersonal skills to collaborate effectively with internal and external stakeholders.
• Strong organizational skills and the ability to effectively prioritize and handle multiple tasks within demanding timelines.
• Business level of verbal and written Japanese and English

Qualifications

• Bachelor’s degree or above in Accounting or Finance. CPA or equivalent qualification

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

【Main Responsibilities】

Supports new product launch projects and associated Quality & Compliance activities in accordance with established company policies/procedures and applicable governmental regulations:

• Supports Regulatory GMP Compliance Inspections of foreign and domestic manufacturers for New Product Applications, Partial Change Applications, and Periodic GMP inspections, including support for remediation of any GMP gaps.
• Participates in cross-functional new product launch projects to support Quality & Compliance activities.
• In collaboration with Manufacturers and Regulatory functions, manages the Conformance Review Process to evaluate compliance of site practices against the marketing authorizations.
• Establishes and maintains local procedures for above activities.

In addition, supports the following Quality Assurance activities of the Marketing Authorization Holder:

• Assures Quality Assurance activities operate within established policies/procedures, global requirements, and all applicable governmental regulations.
• Establishes and maintains robust local procedures to support implementation of all Quality Assurance activities as defined in the GQP regulations.
• Critically assess Quality Systems and their implementation to ensure procedures are followed appropriately. Supports the generation of and tracking of CAPAs, as part of the GQP self-inspection process.
• Drives proactive and continuous improvement of all GQP processes.
• Performs market release of products including management of the release schedule and ensures a robust release process.
• Ensures Quality Agreements are in place with all manufacturers and fully meets the intent and requirements of GQP.
• Coordinates and implements the GQP training program.
• Supports Computer System Validation activities relating to GQP systems.
• Ensures Quality Standard Codes for all company products are maintained as current.
• Supports coordination of any recall activities across a cross-functional team.

Qualification & Experience:

BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.

Must have strong knowledge of and experience in Quality Assurance and/or Quality Control activities. Must have strong demonstrated communication skills in Japanese and English. Must be knowledgeable of applicable regulations governing operations. Highly motivated individual, with strong interpersonal and leadership skills.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.