プロジェクトマネジメント

Global Lead, Medical Affairs, Gastroenterology

職務内容／Job duties （雇入れ直後 / Immediately after hiring） ■配属組織について/About Purpose The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified, fellowship trained gastroenterologist proficient in endoscopy with deep clinical practice knowledge, medical affairs industry experience, and/or health leadership competencies and management proficiencies to effectively deliver expert medical guidance to the Gastroenterology business. Fundamental competencies for this role include: 1.) Gastroenterology disease state, procedural, clinical, and technological market knowledge & experience, 2.) Comprehensive medical affairs proficiencies (e.g., practice insights, care delivery, intended use, clinical impact, and intended therapeutic benefit) spanning from ideation to execution across the product lifecycle, 3.) Capabilities in clinical integration of current and future gastroenterology diagnostic/therapeutic technologies to improve equitable access to care while delivering meaningful clinical and economic outcomes. The GLMAG is part of the growing Medical Affairs division within the broader Medical and Scientific Affairs (MSA) of Olympus. The intended purpose of this role is to support the Gastroenterology global leadership team as an applied medicine expert for medical strategy development and to champion the patient and provider prospective. This role requires the application of prior clinical knowledge and medical training to lead internal stakeholders within the Gastroenterology therapeutic area while simultaneously demonstrating proficiencies in external scientific engagement via peer-to-peer consultations with physicians, payors, professional societies, patient advocacy groups, as well as health system and integrated delivery networks worldwide. The successful candidate will bring a combination of strategic mindset, strong operational involvement (“hands on mentality”), together with a personality of being a team player, humble and inquisitive, along with servant leadership skills and the ability to influence across matrixed internal & external environments. ■職務内容/Primary Duties and Responsibilities PRIMARY DUTIES AND RESPONSIBILITIES* (List of 8 – 10 key tasks required of the job which are essential to the performance of this job. LIMIT OF 4,000 CHARACTERS) •Medical Strategy: Provide expert medical and clinical insights to inform the effective development of the Gastroenterology medical strategy through internal and external engagements while providing continuous input to ensure that the strategy remains clearly defined and consistent with business objectives. •Medical Affairs: This GLMAG is an applied medicine subject matter expert within the Gastroenterology therapeutic area responsible for providing medical practice insights, intended use, and anticipated clinical impact. This spans the product lifecycle through all phases of product development (Initial Conceptualization → Product Development → Launch Excellence → Lifecycle Management) and will include internal as well as external scientific HCP (peer-to-peer) as well as societal engagement. •Clinical Research: To support the Global Head of Clinical Affairs in the conception, development, and implementation of impactful clinical investigations to arrive at relevant study designs by providing applied medicine therapeutic expertise to the clinical team (e.g., practice insights, care delivery, clinical impact assessments, and intended therapeutic benefit). •Clinical Evaluation: The GLMAG will support the Clinical Evaluation team through consultations on literature search strategy, data appraisal, threshold of performance, and assessment of clinical benefits. Contributing authorship of Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER), Summary of Safety & Clinical Performance (SSCP) and Periodic Safety Update Report (PSUR) is expected as well as providing input on equivalent comparators, state of the art, to substantiate safety and performance. •Clinical Care Integration: Demonstrate proficiencies in understanding and facilitating the coordination of patient care, (including care redesign), across conditions, providers, settings, and time to achieve care that is safe, timely, effective, efficient, equitable, and patient-centric. •HEMA/HEOR: The GLMAG will support health economic outcomes research for market access (coverage, coding, reimbursement) by aligning MSA HEMA resources in the most appropriately manner. •Therapeutic Area Expertise: Support the Gastroenterology business strategic goals by providing critical insights obtained through productive peer to peer physician and societal scientific engagements. •Scientific Platform: Provide critical input for the patient care pathway, as well as the Scientific Communication Strategy and Publication Strategy. Responsibilities also include supporting responses to Medical Information Requests (MIRs). •MSA Strategy: Responsible for advocating the Gastroenterology business’ unique needs to be incorporated into the MSA strategy as well as operationally through infra-structure advancements, SOPs, best practices, trainings, and work instructions over a 3–5-year time horizon. •Medical Safety: Engage with cross-functional team members in Medical Safety and Infection Prevention Control to provide DU expertise pertaining to risk management, design controls, health hazard assessments, complaints assessment, CAPAs, nonconformances, and benefit risk determinations. •GI Leadership Team: Serve as a member of the GI Business leadership team to provide input on state of the art within the therapeutic space as well as medical affairs strategy for scientific engagement. Support to the Medical & Scientific Affairs subfunctions in their interactions with the Gastroenterology global team is expected. •Global Business Partners: Collaborate effectively with the growing community of partners including Legal, Finance, Data Privacy, Product Security, IT-Cybersecurity, Intellectual Property, HR, Health Care Compliance, Procurement, and Supply Chain. •Promotional Material Copy Review: Fulfil the role as the medical expert within the Gastroenterology business to provide clinical practice insights to support and assist the team responsible for the review of promotional materials. When necessary incorporate new medical insights to adapt and evolve these materials to regional and global ever changing practice patterns. •Business Development: Provide medical/scientific input into Business Development, R&D, marketing, and greater Gastroenterology business strategies, based on their knowledge and medical expertise. Guide teams to understand what is medically important in digital product design, development, and lifecycle management. Provide integration strategy and operational implementation guidance for acquisitions. （変更の範囲 / Scope of change） 会社の定める業務 Business as defined by the company 【採用人数】 1名   応募資格／Qualifications 【必須要件】 ■Core Competencies： •Strategic Mindset: Weighs long-term consequences and implications associated with actions or events; sees relationships between diverse systems, organizations, or environments; considers problems from a range of perspectives before making decisions. •Organizational Savvy: Understands how work gets done in matrixed organizations; builds productive relationships that allow him/her to efficiently drive projects; maintains a results orientation within constraints of formal organizational policies and rules. •Customer Focus: Builds productive relationships with internal and external stakeholders; stays cognizant of stakeholder needs, concerns, and satisfaction; responds promptly to stakeholder questions and requests; effectively manages stakeholder expectations. •Situational Adaptability: Maintains a positive attitude in the face of change; appropriately adjusts behaviour and activities to changing conditions in the business environment. ■People Competencies •Driving for Results: Aggressively pursues challenging goals and objectives; willing to devote considerable time and effort to accomplish objectives; takes a highly focused, goal driven approach toward work. •Ensures Accountability: Clearly defines and communicates roles and responsibilities; holds people accountable for accomplishing objectives; recognizes and rewards people who achieve results and deliver on performance expectations; provides effective feedback on performance. ■学歴/Education： Required: •Medical Doctor (MD) degree, with demonstrated independent clinical practice experience •Gastroenterology Fellowship Trained Preferred: •Additional advanced degrees: PhD, MS, MBA, or MPH desired •Active participation in a Maintenance of Certification (MOC) program •Active medical license ■経験/Experience： •10-12+ years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training, and education. •Deep knowledge of the Gastroenterology therapeutic area and global understanding of medical affairs, clinical evidence development and global healthcare delivery systems. •Success in product support and ability to bring strategic insight to commercialization plans in respective therapeutic area. •A track record of executing medical and/or scientific plans in support of product differentiation, addressing healthcare stakeholder needs, and clinical practice patterns on a global level. •Ability to understand current evolving environmental and market access issues. •Success working in a matrixed organization, partnering with multiple internal & external stakeholders to deliver against the business unit strategy. •Ability to think strategically, critically assess and synthesize complicated data and scientific information. •Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration. •Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required. •Leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals. •written and verbal communication skills, including the ability to communicate effectively at all levels of the organization. •Vitality flexibility to commit to a global schedule navigating multiple time zones with extended hours into t and scheduling he early morning as well as late evenings (e.g., Eastern Standard Time: UTC-5, Central European Time: UTC+1, and Japan Standard Time: UTC+9) ■Other Considerations •Domestic and international travel 40-50%, including weekend and evening travel as needed. ■語学/Language Proficiency： 英語ビジネスレベル以上（必須）/Fluent in English 日本語ビジネスレベル以上（尚良）/Fluent in Japanese 【選考フロー】 書類選考 → 面接3回（状況に応じて面接回数が増える可能性があります） ※面接は基本webでの実施です  待遇／Salary & Benefits 【雇用形態】 正社員（試用期間3ヶ月：待遇の変更はなし） 【勤務時間】 8：45〜17：30 （休憩：昼45分） 　標準労働時間8時間 ※フレックスタイム制度あり（管理職採用の場合対象外） 　コアタイム11：15〜13：30 ※時短勤務制度あり ※テレワーク勤務あり・時間外労働あり 【休暇・休日】 ・休日　　：土日祝、年末年始、GW、夏期休暇 ・年間休日：129日（自社カレンダーに応ず） ・有給休暇：20日間の年次有給休暇を付与。 ※入社初年度は入社月にて変動します（最大20日） ※時間単位での取得も可能です（一部条件有） ・育産休暇：取得実績あり（2022年度育児休暇取得率：女性94％※1、男性70.2％） ・特別休暇：結婚、出産、忌引き、転勤　など ・私傷病特別休暇 ・治療との両立に伴う特別休暇（厚労省が支援を推奨する疾病に対して、特別休暇を付与） ・リフレッシュプラン ※対象年度の出産者の育児休業取得率は100％であるが、出産者の産後休暇が期間内に含まれるため94％となっています。 【保険】 社会保険完備（雇用保険、健康保険、厚生年金、介護保険、労災保険） 【福利厚生】※1 退職金制度：確定給付企業年金、確定拠出年金 育児サポート：企業内託児所、出産祝い金、ベビーシッター補助※2 その他：従業員持株会、財形貯蓄、カフェテリアプラン※3、社内食堂、社外シェアオフィス、健康診断※4、団体保険 ※1）記載の福利厚生については各種規定、条件がございます ※2）内閣府企業主導型ベビーシッター利用支援事業 ※3）自己啓発、健康増進、育児・介護支援など様々なメニューから選択して利用できます ※4）35歳以上の方は健康診断で内視鏡検査を受診する場合は全額補助が出ます   勤務地／Location （雇入れ直後 / Immediately after hiring） ■*グローバル本社（東京都八王子市石川町2951） 働く場所は在宅・新宿サテライトオフィス・宇津木事業所・シェアオフィス（社外）なども可能です。 活用方法や頻度は部署と職種により異なります。詳細は面接時にご確認願います。 *新宿サテライトオフィス（東京都新宿区西新宿2-3-1 新宿モノリス） *宇津木事業所（東京都八王子市久保山町2-3） 【受動喫煙対策】事業場内禁煙 （変更の範囲 / Scope of change） 会社の定める場所( テレワークを行う場所を含む) Workplace determined by the company(including the location where the telework will take place)