דרושים Senior Therapy Development Specialist Electrophysiology Apac ב-Boston Scientific ב-Japan, Tokyo

Accelerate Portfolio Commercialization in APAC with strategic focus on China and Japan

• Represent APAC as the voice for key strategic products and clinicals at global divisions plan reviews
• Attend global Franchise Leadership team meetings, both remotely and periodically in person to represent APAC needs and provide regular updates on projects, influence divisional priorities and drive key decisions around investment and prioritization based on business plans
• Partner with division and leadership teams in markets to identify key strategic products to find accelerated pathways to market by working cross-functionally and globally
• Establish a clear cadence of Geographic Expansion for Markets/ APAC top ten products and ensure a business case is developed for each (relevant to division and franchise)
• Support business cases to include cross functional input on investments, costs, and top line assumptions; partner with functional leaders in APAC and in country to drive this, and with sales and marketing teams to ensure alignment on topline projections
• Ensure that each key project for commercialization has a detailed regulatory, reimbursement, medical/clinical affairs workstream which is led by cross functional APAC partners, but this team project manages the consolidated workstream
• Lead new product commercialization plans at franchise leadership team meetings and drive decisions for investment (clinical/ medical, HEMA, Reg, any other pre commercial workstreams)
• Represent APAC voice of customer (VOC) for key strategic products and clinicals at global divisions plan reviews
• Communicate KPIs and key milestones for identified high growth margins and strategic products pre-commercialization investments and instill tracking mechanisms to ensure launch acceleration and transparency among relevant stakeholders in global, region and markets
• Support teams in markets and divisions to find solutions to major barriers and disruptions to achieve commercialization plans
• Work with clinical leads to support portfolio training needs for new products being introduced into APAC markets that require strong clinical trainer support

Understand Portfolio Gaps/ Customer Insights and Connect into Global and Business Development

• Partner with teams in markets to understand key current and future portfolio gaps, identify high-impact growth opportunities that will transform our go to market strategies; Quantify and prioritize these and feed these back to BD and Global Division during all portfolio discussions and identify collaborative solutions to address the problems
• Function as a bridge and force multiplier amongst region, corporate division marketing and country commercial teams to ensure APAC’s most important product opportunities and gaps are clearly quantified and communicated
• Strong sense of region’s customer insights and market conditions to be able to identify the right portfolio opportunities and strategies. This includes ensuring key APAC KOLs have representation at Global Divisions’ advisory boards and lobby for these partnerships with markets
• Participate in Ad Board meetings in markets and develop understanding of portfolio needs
• Partner with divisional, regional, and medical affairs teams in markets to ensure appropriate APAC representation in pre and post market clinical trial and publication activities

Identify and roll out Pre-commercialization Investment Plans for APAC

• Have a clear understanding of how clinical investments at global and regional trials are identified and ensure that APAC sites are included and prioritized by markets/ region at global division’s investment and launch plans
• Ensure that APAC specific evidence for Health Economics and Market Access Reimbursement is communicated to and aligned with the global clinical trials team that can help gain differentiated reimbursement and get a head start on competition/ accelerate launches
• Support division and local leadership to increase reimbursement/pricing/GM of key strategic therapy to ensure patient access

Active Portfolio Management

• Review portfolio and product mix for APAC and drive portfolio rationalization in collaboration with teams in markets to move to more profitable product mix
• Ensure there is keen understanding within the global division around the relevant product portfolio and sustaining efforts required for APAC markets

Building and Maintaining Relationships

• Identify, establish, and maintain personal contacts with key KOLs in APAC to help keep key customers engaged and close to BSC (where needed by markets)
• Develop on going communication and relationships with key global counter parts. Reach out early, share information and take out the time to share markets and regional strategy and needs
• Develop on going communication and relationships with key function areas including Regulatory, Clinical, Finance, Supply chains, and other related functions to ensure strong functional collaboration to drive alignment in support of pre-commercialization activities

Planning and Analysis

• Develop and coordinate divisional portfolio plans and product pipeline to achieve APAC and divisions business goals and input this into markets and divisional strategy plans

Downstream Marketing Activities Support

• Enable markets and divisional collaboration by supporting key downstream and commercialization activity (like what regional teams currently do - ONLY for big/ strategic problems and opportunities)

Japan-Tokyo; Hong Kong-Hong Kong; Taiwan-Taipei City

Purpose Statement

Electrophysiology (EP) is an exciting growth driver for Boston Scientific. With the acquisition of FARAPULSE Inc. and global introduction of pulsed field ablation technology, Boston Scientific (BSC) has strengthened its leadership in Personalized EP Solutions, with a strong focus in Atrial Fibrillation. As an EP Development Specialist in the Asia Pacific region, you will be a key technical partner for the clinical and commercial teams supporting the expansion and informing the future pipeline of BSC EP technology. This role will require strong physician engagement skills surrounding BSC products as well as translation and clinical science.

This position requires a hands-on technical expert who can effectively communicate with a variety of internal and external stakeholders. Given the vast investments in our EP R&D Pipeline, this is a critical role with high visibility which will provide the right candidate with excellent growth potential.

Key Responsibilities

• Develop expertise in all BSC EP technologies and portfolio, including all ablation and mapping technologies
• Develop subject matter expertise in pulsed field ablation technology and provide support to regional commercial partners
• Support customer engagement programs during national / international congresses or following specific requests from the commercial sales and marketing organizations, including preclinical studies
• Facilitate collaborative research projects with leading academic institutions in order to advance BSC electrophysiology products
• Network with a variety of stakeholders to collect and analyze voice-of-customer feedback
• Network with the field and with KOLs to follow closely competitive activities
• Provide strategic input into the development of future products through partnership with divisional/global R&D partners
• Support the advancement of global product development initiatives through analysis of technical data during Limited Market Release or during early phase clinical trials
• Provide technical insights to both Medical Affairs and Marketing during new product/software launches

Key Qualifications

• Advanced Engineering Degree, minimum Master’s degree (or equivalent), PhD is a plus
• Field or research experience with BSC or competitive EP technologies including mapping and ablation platforms, minimum 3 years
• Demonstrated ability to work independently across complex organizational boundaries
• Excellent oral and written communication skills,business level proficiencyin Japanese & English to enable effective collaboration with individuals across the APAC region
• Data analysis skills, Statistics and proficiency in Matlab are a plus
• High flexibility to travel in APAC region (25-50% travel)

ROLES & RESPONSIBILITES

Responsibilities include, but are not limited to:

• Prepare draft legal opinions in response to queries raised
• Perform preliminary review of the legal aspects of project proposals, draft agreements, correspondence, and other texts and provide appropriate comments
• Draft or assist in the drafting of legal documents for the final review of a supervisor
• Draft legal memoranda and other legal documents including administrative contracts and agreements such as contracts of engagement of personnel, consultants, and contracts awarded for the procurement of goods or services
• Prepare and follow up on filings before national entities to establish, maintain, and protect the intellectual property and other legal commercial rights
• Prepare draft recommendations concerning intellectual property and commercial issues
• Prepare, review, draft, and negotiate copyright, trademark, and patent license agreements
• Assist in the preparation of briefs to represent in proceedings before appeal bodies and administrative tribunals as well as other judicial or quasi-judicial bodies
• Assist in the selection and analysis of relevant international and national legal materials for the preparation of reports or legal opinions
• Prepare background materials, reports, papers, and other documents as requested by the supervisor

JOB REQUIREMENTS & COMPETENCIES

• Over 5 years of experience in corporate legal affairs within Japan, preferably in the medical device or pharmaceutical industry.
• Experience with contract management solutions
• A minimum of 3 years of experience drafting commercial contracts preferred
• Superior verbal and written communication skills for multiple audiences including staff, management, and senior executives both in Japanese and English.
• High integrity and excellent sense of confidentiality.
• Willingness to learn about different areas based on the needs of particular tasks.
• High proficiency in Microsoft Office product suite (including Word, Excel, and PowerPoint)
• Meticulous attention to detail and quality of work product
• Ability to work as a collaborative and proactive member of a team.
• Ability to work in a fast-paced environment and within tight deadlines.
• Strong interpersonal and communication skills with agility.
• Ability to communicate and deal effectively with diverse individuals at all organizational levels
• Professional, personable, approachable, and courteous demeanor
• Demonstrate good judgment and professionalism, and exhibit flexibility and versatility to provide support
• University graduate in Law or related discipline is preferrable

責任には以下が含まれますが、これに限定されません：

• 問い合わせに対する法的意見の草案を作成する
• プロジェクト提案、契約書、書簡、その他の文書の法的側面を予備的にレビューし、適切なコメントを提供する
• 上司の最終レビューのために法的文書を作成または作成支援する
• 法的メモランダムやその他の法的文書（人員、コンサルタントの契約、物品やサービスの調達契約などの行政契約や合意書を含む）の草案を作成する
• 知的財産やその他の法的商業権利を確立、維持、保護するために国内機関への提出書類を準備し、フォローアップする
• 知的財産および商業問題に関する推奨事項の草案を作成する
• 著作権、商標、特許ライセンス契約を準備、レビュー、作成、交渉する
• 上訴機関や行政裁判所、その他の司法または準司法機関での手続きにおける代表のためのブリーフを準備する
• 報告書や法的意見の作成のために関連する国際および国内の法的資料を選択し、分析する

求められるスキルと能力

• <必須>日本国内での企業法務の経験5年以上、医療機器メーカーもしくは製薬業界が望ましい
• 契約管理ソリューションの経験
• 商業契約の作成経験が3年以上あることが望ましい
• 日本語および英語でのスタッフ、管理職、上級幹部を含む複数の対象者に対する優れた口頭および書面でのコミュニケーションスキル
• 高い誠実性と優れた機密保持感覚
• 特定のタスクのニーズに基づいて異なる分野について学ぶ意欲
• Microsoft Office製品スイート（Word、Excel、PowerPointを含む）に高い熟練度
• 細部への注意と高品質な作業成果物
• チームの協力的かつ積極的なメンバーとして働く能力
• 速いペースの環境で、厳しい締め切りの中で働く能力
• 機敏な対人およびコミュニケーションスキル
• 組織のあらゆるレベルの多様な個人と効果的にコミュニケーションし、対処する能力
• プロフェッショナルで、親しみやすく、礼儀正しい態度
• 良識とプロフェッショナリズムを示し、サポートを提供するための柔軟性と多用途性を発揮する
• 法学または関連分野の大学卒業者が望ましい
• 弁護士資格保有者 なお可(必須ではない)

Job title: Senior Specialist, Regulatory Affairs

各製品ラインの迅速かつタイムリーな承認を確保するために、すべての製品登録に関する計画を立て、登録準備および関連書類の管理を行います。

• Provides input on regulatory related issues associated with compliance and achieving the business plan.
• Prioritize and plan on product registration for his/her respective product.
• Preparing, coordinating and submitting regulatory applications to the local health authority.
• Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.
• Provide the management team with regular updates on product registration.
• Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
• Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
• Supports tender operations by timely supply of accurate regulatory.
• Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
• Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
• Serves as regulatory consultant to marketing team and government regulatory agencies.
• Complete the mandatory Quality training subject to the defined timeline. And ensure compliance with internal Quality system and policy.

• コンプライアンスおよび事業計画の達成に関連する規制関連の課題について、意見を提供します。
• 担当製品の登録を優先順位付けし、計画を立てます。
• 規制当局への申請書類の準備、調整、提出を行います。
• 承認待ちの状況を常に把握し、登録がスムーズに進むように支援します。
• 製品登録の進捗状況について、経営陣に定期的に報告します。
• 規制当局との信頼関係を維持するため、定期的な会議、ディスカッション、トレーニング、教育を通じて関係構築・維持の計画を立て、実行します。
• 規制に対して建設的かつ科学的な視点から異議を唱え、代替案を提示することで、規制当局への働きかけを行います。
• 入札業務を支援するため、正確な規制情報をタイムリーに提供します。
• 医療機器業界団体と関係を築き、業界の仲間と協力して規制当局に働きかけ、現地の政策に影響を与えます。
• 文書作成において、地域のRA（Regulatory Affairs）担当者と良好な関係を築き、迅速かつ前向きなサポートを得られるようにします。
• マーケティングチームおよび政府の規制当局に対して、規制に関するコンサルタントとしての役割を果たします。
• 定められた期限内に必須の品質トレーニングを完了し、社内の品質システムおよびポリシーを遵守します。

【必須経験】

• 医療機器クラスIII以上での薬事経験　２年以上
• 英語：ビジネスレベル
• 既存の戦略やプロセスに固執することなく Proactive に自ら考え立案し交渉できる。
• 事業部、事業部、PMDA、グローバルとの難しい交渉を単独でマネージできる、グローバルとの難しい交渉を単独でマネージできる。
• すべての情報が揃わなくても動き始めるAgilityがある。
• 変化を前向きに解釈し前に進む。
• 臨機応変に変化を捉える。

【Want要件】

Boston Scienftific

Strategic Partnerships & Alliances:

• Lead the end-to-end M&A process, including target identification, financial modeling, valuation, due diligence, negotiation of terms, and integration planning
• Identify, evaluate, and cultivate strategic partnership opportunities (e.g. joint ventures, co-development agreements, distribution partnerships) that expand market reach, enhance product offerings, or generate new revenue streams
• Lead the negotiation and structuring of complex partnership agreements, ensuring mutually beneficial terms and successful long-term relationships
• Manage existing key strategic partnerships, fostering strong relationships and identifying opportunities for growth and expansion

Business Development:

• Proactively identify and assess new business opportunities, market segments, and emerging therapies that could drive future growth for Japan and key APAC countries
• Conduct competitive analysis and trend analysis to inform strategic decision-making
• Build and maintain a robust pipeline of potential targets and strategic partners
• Represent the company (in accordance with country leadership) at industry conferences, networking events, and meetings to identify new opportunities and build relationships

Financial Analysis & Valuation:

• Perform comprehensive financial modeling, valuation analysis (DCF, multiples etc.), and synergy assessments for targets and partnership opportunities

• Develop detailed business cases and ROI analyses to support investment decisions

Leadership & Collaboration:

• Collaborate closely with executive leadership, product, engineering, sales, and marketing teams to ensure alignment of M&A and partnership strategies with overall company goals
• Act as a trusted advisor to senior management on market dynamics, competitive landscape, and strategic growth initiatives

KEY QUALIFICATIONS

• Bachelor’s degree in business administration, Finance, Economics, or a related field. MBA is highly preferred
• Minimum 8-10+ years of progressive experience in M&A, investment banking, strategic consulting, with a strong focus on deal execution
• Proven record of successfully identifying, structuring, negotiating, and closing transactions and strategic partnerships
• Deep understanding of financial modeling, valuation methodologies, and due diligence processes
• Exceptional analytical, problem-solving, and strategic thinking skills
• Superior communication, presentation, and inter-personal skills, with the ability to influence and build relationships at all levels, internally and externally
• Strong project management skills with the ability to manage multiple complex initiatives simultaneously
• High degree of professionalism, integrity, and discretion
• Ability to thrive in a fast-paced, dynamic, and rapidly evolving environment
• Experience in investing in and structuring deals in Japan/ Medical device industry is a significant plus

Key Responsibilities

• Lead strategic planning efforts, working in partnership with the senior executive team, to develop a fully detailed APAC Business Strategy to include stated objectives and action plans, inclusive of the market mapping, identifying potential gaps and exploiting new opportunities
• Develop the APAC Strat Plan. Develop market strategies aimed at maximizing market share, promoting prolific new product launches and building brand awareness and customer loyalty as well as healthcare economics, government affairs and reimbursement
• Execute ongoing identification of new business/ distribution opportunities and markets, tracking of competitors and market shifts, review of the broad strategic direction
• Collate market research and competitive data to enable the formation of country strategic marketing plan
• Capture and structure information from the field producing updated market mapping and business sizing
• Initiate and lead the development and implementation of customer programs, networks and advisory boards
• Manage and oversee the APAC marketing plan and budget
• Develop, lead and manage the execution of new product launches
• Design & implement conferences/symposium strategies & tactics to support the country plan
• Work with sales managers to ensure country trainers, key sales reps are adequately trained. Sets up physician and staff training and education, patient education events. Monitors post training results by physician to assess cost/benefit
• Work with operations team to manage the supply chain for products – monthly forecasts, managing backorders & planning inventory transitions for new products
• Develop appropriate clinical activities plan – registries, post market studies for divisional studies
• Quantify and prioritize reimbursement opportunities. Work with countries to help execute
• Spend 50% of time in the field helping to convert accounts, executing launches, clinical activities, gathering market & competitor information
• Make regular contact/communication with Divisional marketing personnel and sales/country management to ensure alignment of plans
• Ensure alignment with other functions (Finance, Supply Chain, Health Economics, Marketing, Clinical, Regulatory, Quality)
• Ensure awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of BSC
• Participate in driving quality awareness in every employee, while guiding the local organization towards improved performance and customer oriented initiatives

Key Qualifications

• Minimum undergraduate degree from a reputable university. Candidates with MBAs will be preferred
• Prior knowledge of core products from Urology and Women’s Health is an advantage
• Familiarity with the Japan/Australia/China market and fluency in Japanese/Mandarin would have an added advantage
• Candidates with prior experience in Urology and an understanding of the industry, procedures, solutions is preferred
• Proven track record of successful execution of tasks and possess leadership potential
• Willingness and ability to travel approximately 20% to 30% of the year
• Excellent verbal and written communication skills in English are required
• Ability to work in a fast-paced, demanding environment and multi-task
• Possess strong prioritization, project management and time management skills
• Proficient in Microsoft Excel, Word, and PowerPoint
• Mature and able to articulate ideas and concepts well in front of senior management.Ability to work across different cultures
• Displays drive and ambition to be developed and grow into more senior marketing roles

Purpose Statement

Electrophysiology (EP) is an exciting growth driver for Boston Scientific. With the acquisition of FARAPULSE Inc. and global introduction of pulsed field ablation technology, Boston Scientific (BSC) has strengthened its leadership in Personalized EP Solutions, with a strong focus in Atrial Fibrillation. As an EP Development Specialist in the Asia Pacific region, you will be a key technical partner for the clinical and commercial teams supporting the expansion and informing the future pipeline of BSC EP technology. This role will require strong physician engagement skills surrounding BSC products as well as translation and clinical science.

This position requires a hands-on technical expert who can effectively communicate with a variety of internal and external stakeholders. Given the vast investments in our EP R&D Pipeline, this is a critical role with high visibility which will provide the right candidate with excellent growth potential.

Key Responsibilities

• Develop expertise in all BSC EP technologies and portfolio, including all ablation and mapping technologies
• Develop subject matter expertise in pulsed field ablation technology and provide support to regional commercial partners
• Support customer engagement programs during national / international congresses or following specific requests from the commercial sales and marketing organizations, including preclinical studies
• Facilitate collaborative research projects with leading academic institutions in order to advance BSC electrophysiology products
• Network with a variety of stakeholders to collect and analyze voice-of-customer feedback
• Network with the field and with KOLs to follow closely competitive activities
• Provide strategic input into the development of future products through partnership with divisional/global R&D partners
• Support the advancement of global product development initiatives through analysis of technical data during Limited Market Release or during early phase clinical trials
• Provide technical insights to both Medical Affairs and Marketing during new product/software launches

Key Qualifications

• Advanced Engineering Degree, minimum Master’s degree (or equivalent), PhD is a plus
• Field or research experience with BSC or competitive EP technologies including mapping and ablation platforms, minimum 3 years
• Demonstrated ability to work independently across complex organizational boundaries
• Excellent oral and written communication skills,business level proficiencyin Chinese & English to enable effective collaboration with individuals across the APAC region
• Data analysis skills, Statistics and proficiency in Matlab are a plus
• High flexibility to travel in APAC region (25-50% travel)