【担当職務(1、2のいずれか)】
1.　商品企画担当
・体外診断機器（IVD医療機器）・診断薬（免疫（腫瘍マーカー、感染症など）、生化学）の新規商品企画
　　
2.　学術推進担当
・体外診断機器（IVD医療機器）・診断薬（免疫（腫瘍マーカー、感染症など）、生化学）の学術活動の遂行

■ 職務内容 / Job Description
Job Description (職務記述書)/Accountability (責任や権限の範囲)
The HEOR lead position will be responsible for leading the planning, development, implementation, and communication of relevant health economics and health outcomes evidence strategies. This position will work closely with other functions to add value, secure reimbursement, patient access and utilization of AZ products.

Responsibility/Key Tasks (具体的な職務内容)
- Lead the planning, development, implementation, and communication of relevant health economics, health outcomes (e.g., patient-reported outcomes), or real world evidence strategies to support relative value demonstration and product differentiation for AZ products
- Work proactively and collaboratively with related internal functions to develop value proposition and to identify data/evidence requirements for each priority product, and execute HEOR research studies to meet requirements in order to support brand/medical/Access strategies
- Manage the implementation of HEOR studies and support the development of value messaging, scientific communication plans and customer-facing dissemination tools
- Develop relationships and work closely with key opinion leaders and academic researchers throughout the research/dissemination cycle
- Work with clinical teams to plan that appropriate health economics/outcomes information is collected in the course of clinical trials
- Serve as internal resources for continuous education regarding concepts commonly defined through health economics and health outcomes research principles (e.g., cost-effectiveness analysis, budget impact analysis, patient-reported outcomes, and patient preference)
- Attend industry meetings as assigned to keep abreast of key market developments

■休日：完全週休二日制, 年末年始

Job Purpose
￣￣￣￣￣￣
■Responsible for implementing the Medical Affairs Plan of asthma and COPD inhaled medicine strategies, driving a consistent approach to carrying out scientific engagement activities internally and in the field; ensuring compliance with all relevant regulations and GSK policy/code of conduct
■Effectively develop strong strategic relationships with key influencers and external organizations to ensure that GlaxoSmithKline retains a leading voice within the therapeutic areas in Japan.
■Co-ordinate and utilize specialist knowledge and align with cross-functional brand colleagues to formulate and implement short- and long-term medical strategy for access and use of GSK medicines

Key Responsibilities
￣￣￣￣￣￣￣￣￣
■Key role in developing Medical Strategy for GSK medicines
■Provide analyses and reviews of GSK products, therapy areas and competitor products, making recommendations, which assist marketing in the determination of current and future strategic direction.
■Key role in the planning and development of promotional and educational campaigns, with responsibility for
・scientific content (core claims) of materials ensuring the data maximize commercial potential.
・medical accuracy and compliance with the product license and the relevant Codes of Practice
・training materials and training of relevant MSLs
■Provide and collaborate with the MSL team to develop scientific tools required for them to successfully perform their job (e.g. scientific platform content, presentation of new data, therapy area reviews, product monographs, slide sets, training packages etc.) as appropriate to business and customer needs.

■休日：完全週休二日制, 年末年始

Job purpose:
￣￣￣￣￣￣
MSL Manager is accountable for leading and driving performance of MSL department in corresponding therapeutic area.
MSL Manager drives MSL department by setting the right business objectives and priorities aligned with global counterpart to ensure the delivery of the Medical plan and safe and effective use of GSK medicines.
MSL Manager develops the capabilities of MSLs to achieve world-class scientific engagement by MSL team.
MSL Manager acts as a role model, mentor and coach for MSLs to develop/improve their skills and capabilities.
MSL Manager collaborates with the Commercial and clinical counterparts to implement the Medical plan effectively.


Key Responsibilities
￣￣￣￣￣￣￣￣￣
MSL Manager is accountable for the MSL department and reports into Head of corresponding therapeutic area.
MSL Manager leads the MSL department to develop and implement the external engagement plan in accordance with the pre-defined strategy within the framework of medical reflection.
MSL Manager is accountable for MSL performance and KPIs in line with GSK global standard.
MSL Manager ensures the team to build a world-class scientific relationship with identified External Experts(EEs) in the corresponding therapeutic area.
In order to achieve medical/business goal, MSL Manager builds high performance MSL team to lead and develop/improve the capability of MSLs.
MSL Manager ensures that the team is engaged and progresses, by identifying training needs.
MSL Manager evaluates the skills of MSLs, detects areas for potential and defines the path for development.
MSL Manager helps MSLs to build peer-to-peer scientific relationship with EEs to deliver high quality mVOC/medical insights to GSK stakeholders in the medical, development and commercial teams.
MSL Manager helps to develop an effective Medical Affairs plan and owns the operation of the Medical plan in collaborate with others in Medical Affairs.
MSL Manager coordinate and negotiate with other part of GSK functions to bring and show the value of MSL as scientific expert function.
*Future scope of job and working location will be determined by company.

■休日：完全週休二日制, 年末年始

Job purpose
￣￣￣￣￣￣
メディカルアドバイザーとして、医療・科学的観点から患者アウトカムの向上に貢献する

Key responsibilities
￣￣￣￣￣￣￣￣￣
■メディカル戦略の立案に医療・科学的観点から貢献し、それに基づいたプロジェクトを遂行する
■メディカル戦略の立案において医療・科学的観点からMedical Leadにinputする
■社内ステークホルダーに対して、医療・科学的観点からサポートする
■Medical活動やその他のNon-Promotional活動、Promotional活動が社内および国内外のガイドラインを遵守しながら、医学的・科学的に正しく遂行されることを担保する
■Key opinion leaderやKey authoritiesと科学的なディスカッションができ、良好なコミュニケーションをとる
■GSKの製品に対して、メディカルとして適切な情報提供をする
■社外ステークホルダーとメディカル戦略を最大化するためのコミュニケーションをとる

■休日：完全週休二日制, 年末年始

目的：GSK Japanの主要製品に係るメディカル・Data Generation活動において、リスク・予算・ステークホルダー及びリソースマネジメント等のプロジェクトマネジメントの専門性を発揮し、関連部署と連携し、また調整を図りながら会社戦略に準拠したメディカル・エビデンスプランの立案と確実な遂行を達成する。

案件により、市販前の段階からコマーシャル、生産、GAMAも含む組織横断的なチームを形成し適切な戦略立案と実行がなされるように取り計らう。

業務内容：下記に例示するプロジェクトマネジメント業務の遂行（なお、下記の内容に限定されるものではない）

各種事案の進行・問題解決に係る意見調整、自らの参画を通じた組織横断的チームの運営管理
スケジュール・予算・リソース・リスク管理、進捗状況のトラッキング
社内意思決定会議体（例：Japan Strategy Review）への計画提案の調整、事前準備及び事後のフォローアップ
チーム会議の設定、議題及び意見調整、進行、議事録作成

■休日：完全週休二日制, 年末年始

自社製品のMedical Plan及びTactics，予算を立案し，上級管理職から承認取得に責任を負う．この過程においては国内及び海外グループ会社，並びにアライアンス企業の関連部署との協力体制を取る．また，定期的にMedical Plan/Tacticsの進捗を管理し，課題解決をリードする．
メディカルアフェアーズ部にて立案される研究計画をレビューし，Brand PlanやMedical Planとの整合性や，研究シノプシスの妥当性を確認する．研究開始後は担当者による研究実行をサポートする．
担当領域/製品のPublicationについて，科学的インプットを行う．
メディカルアフェアーズ部における領域/製品の代表として，社内の研究開発，マーケティング等の部門との協同を行う．

※将来的に会社の定める業務へ変更となる場合があります

■休日：完全週休二日制, 土, 日, 祝日, GW, 年末年始

1. 医療関係者及びMRからの電話・メールによる、問合せの対応を行う。
・1次対応者が添付文書、インタビューフォーム、FAQで回答できなかった電話による問合せを引き取り、回答する。
・メールによる問い合わせに対し、電話もしくはメールで回答する
2. 1次対応の教育資料を作成する

※将来的に会社の定める業務へ変更となる場合があります

■休日：完全週休二日制

■　Responsibilities and Accountabilities
・Compliance Structure and Programs

 Develop a thorough understanding of the Company’s business, markets, and third parties, to identify trends and implement appropriate programs, plans and strategies that aligns with the organization's goals and objectives.
 Stay abreast of changes in laws and regulations that may impact the organisation’s compliance obligations.
 Establish effective communication channels to promote a culture of compliance, leadership, and personal accountability within the organization.
 Lead the internal Compliance Steering Committee and Third-Party Due Diligence Programs. Collaborate with different departments to ensure that compliance requirements are integrated into business processes.
 Develop and ensure robust records keeping system and processes.
 Conduct risk assessments to identify areas of potential compliance vulnerability and collaborate with relevant stakeholders to develop and implement risk mitigation strategies.
 Prepare and submit regular reports to senior management and regulatory bodies regarding the status of the compliance program.

・Compliance as a business partner

 Contribute to the development of country specific compliance policies and procedures and code of conduct; conduct compliance trainings (internal and external stakeholders) periodically and maintaining training records.
 Deliver targeted compliance training programs for internal and external stakeholders periodically and maintaining training records, to promote awareness and understanding of compliance requirements.
 Review and monitor sales and marketing promotional materials and business proposals, along with the relevant stakeholders, to ensure it is in line with company compliance policy, guideline, local statutory rules as well as relevance laws and regulations.
 Conduct periodic reviews and monitoring to ensure areas of the business are operating in accordance with relevant laws and regulations, as well as internal policies and procedures and provides recommendations for compliant business activities.
 Advise country management and functional leaders on new/ proposed legislation, implement sensible changes to Company’s compliance program to comply with new regulatory requirements and/ legislation.
 Interpret and communicate complex regulatory requirements in a clear and understandable manner. Serve as a trusted advisor to business units on compliance matters, providing timely and practical guidance.
 Develop and implement procedures for addressing compliance violations and incidents. Lead and/or assist in internal compliance investigations, compliance monitoring activities, and compliance audits.
 Lead, in coordination with regional compliance/HQ on projects, manage
communication of resulting reports/ recommendations and support any required business remediation plans / corrective actions.
 Perform other related duties and special projects as assigned by General Manager and/or Regional Compliance Director.

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始

■Job Description Summary
-Lead scientific engagement with their Medical Experts. Implement clinical and educational strategies and respond to unsolicited medical enquiries. Lead field medical activities in collaboration with cross-functional teams and mentor other Field Medical associates.

■Major Accountabilities
・Provide excellent coaching for MSL members to continuously improve actionable insight generation and establish a strong strategic long-term engagement with HCP/HCS. Approximately 50% of the MSL group manager’s time should be spent on coaching.

・Collect and generate actionable insights from HCP/HCS/Patients on healthcare ecosystem and treatment landscape both at national and area-specific level, to be incorporated into Novartis launch strategies and tactics

・In collaboration with MSLs and the Medical Lead, creation of field medical strategic and tactical plans (MEEP), aligned with Japan medical franchises and Medical Excellence and Execution. Accountable for execution of plans.

・Create/Drive improved treatment pathways in collaboration with MSLs, Medical Lead and other relevant functions (e.g. V&A, Ecosystem), engaging with National/Local HCP and HCS

・Up-to-date scientific training of field medical team to support timely and robust scientific discussion with HCP/HCS

・Guideline related communication to ensure appropriate positioning and patient access

・Provides holistic view of Japan MSL effectiveness through the development and analysis of KPIs, reporting dashboards, and Japan MSL value communications to leadership; communicates Japan MSL value and impact to the broader organization

・Support RC/IIT

■Key Performance Indicators
・Quality and quantity of field medical activities and actionable insights
・Voice of Customer feedback on scientific quality of MSL interactions
・Customer NPS score in relation to trust and reputation

■休日：完全週休二日制, 土, 日, 祝日, GW, 年末年始

■Summary
Job Purpose: Monitor and communicate regulatory intelligence and policy information to facilitate decision making for compliant and quality global development aligned with business objectives.

■About the Role
・Major Accountabilities
Monitor and search relevant laws, guidelines and other regulatory information published on Health Authority webpages and databases, public conferences, workshops and press.
Collect and communicate intelligence, learning from Scientific Advice and/or other health authority advisory boards (e.g., FDA Advisory Committees) for our products to RA DUs, Regions and Functions as appropriate.
Contribute to internal knowledge management systems and produce analyses reports.
Prepare and coordinate internal Novartis feedback from cross-functional teams on draft regulations and guidelines
Communicate new and emerging regulatory requirements to RA colleagues and relevant line functions via written communication, such as newsletters, information e-mails.
Support internal activities for the development of policy strategies and advocacy plans.
Make presentations, as appropriate, as a means to communicate new or evolving regulatory requirements.

・Key Performance Indicators
Proactive communication of new and evolving regulatory requirements.
Timely coordination and follow-up of Novartis feedback to draft egislation/guidelines.
Active participation at internal working groups and team meetings
Active contribution to internal presentations (e.g. GREF, GPN, etc.)

■休日：完全週休二日制, 土, 日, 祝日

■Summary
MSLのインパクトフルコミュニケーション実現に向けたCapability向上プログラム実施を主な責務とする。特に、顧客に対して効果的にActionable insightの創出、顧客の行動変容を促すことが実現できるよう、コミュニケーション上の課題を特定し、スキル向上に向けたトレーニングプログラムを企画・実行する。また、MSLのGroup managerに対しても、より効果的なコーチングの活用により、MSLの訪問の質が向上するよう、MSL-Group Manager: MSL-GMに対してコーチングスキルのCapabilityの向上をはかる。

■About the Role
・Major Accountabilities
MSLの現状の顧客に対するコミュニケーションスキルをアセスメントし、Field OJTやロールプレイなどの実践的なトレーニングを企画実行し、ノバルティスで使用しているコミュニケーションスキルのフレームの定着及びレベルアップをはかる
MSL GMのコーチングスキルをアセスメントし、その課題についてTeachingやcoachingをしながら、GMがMSLに対して、自信をもってコーチングできるようプログラムを企画立案、実行していく。
MSL GMに対するコーチング研修とMSLに対するコミュニケーションスキル研修を連動させ、包括的な研修を企画実行する。
現状をアセスメントし、Medical Affairsの主要なステークホルダーの期待レベルとのギャップを正確に把握する。
現状レベルと期待レベルのギャップ評価に基づき、短期および長期のトレーニング計画をする。また実施に際しては、
全てのトレーニングにおいて、その実施方法、評価、評価の測定方法、パフォーマンスや報告については、標準化された方法を確立し、展開する。

・Key Performance Indicators
Upskill of Medical capabilities（MSL GM coaching skill, MSL impactful communication skills）

■休日：完全週休二日制, 土, 日, 祝日

■Summary
RWE and Evidence excellence is responsible for providing strategic oversight and guidance as well as operational support on observational research/ real-world data & evidence initiatives that are pursued by internal teams, such as the Medical Affairs teams. The incumbent must have deep knowledge and extensive experience with Real-world Data (RWD) and Observational Research (OR)/ RWE generation, to partner with the Head of Medical Franchises, HEOR and GDD to lead the co-Integrated Evidence Plan (IEP) at Novartis, and to provide expert guidance and direction to internal teams on local IEP planning, study delivery, strategic data acquisition and building of internal RWE capabilities.

■Major Accountabilities
・CONTRIBUTE TO THE DESIGN AND ANALYSIS OF RWD
◦ Co-lead Data generation planning, implementing and delivering high quality, scientifically robust observational and/or Clinical trials design (i.e. target population, protocol development,sample sizing)

◦ Evaluate and assess strengths and weaknesses of external Real World Data sources for advancing the data strategy for a given therapeutic area.

◦ Design a fit-for-purpose analysis plan, assess effective ways of delivering the results to maximize impact and interpretability

・RECOMMEND DATA SOLUTIONS to address evidence needs.
◦ Ask the right scientific questions, understand the evidence needs and make recommendations on fit-for-purpose data and analytics solutions.
◦ Leverage RWD and technology to propose solutions for enhancing medical practice and patient outcomes (e.g. engagement platforms, TPO dashboard etc.)
・Co-Lead the integrated evidence plan in collaboration with Medical Head /
・Effectively facilitate thoughtful planning, tracking and executing stages for RWE projects to ensure fit-for-purpose solution design, implementation.
・Lead to build Local Real World evidence generation capability and expertise
・Hold the accountability for tracking IIT progress (time/cost/quality) to drive the effective IIT delivery as per the agreed evidence plans in collaboration with MGL
・Guarantee Good Clinical Practices (GCP) and internal procedures compliance in collaboration with MGL.
・Build an internal global-regional-local network to share best practices
・ Manage SRB Office and act as SRB Reviewer
・Act as Other SUD Reviewer
・ Act as RWE center of excellence core member
・ Act as TPO champion

■Key Performance Indicators
・Accelerate the SUD first culture (ratio SUD/PDC)
・Achievement of target patient outcomes
・Time, cost, quality and impact of evidence generation
・Continuous improvement of RWE talent pool

■休日：完全週休二日制, 土, 日, 祝日

【Role Purpose】
The Lead, TA Medical or Associate, TA Medical is accountable for building responsible brand or disease area medical strategy and ensuring its execution in collaboration with MSLs, MSEs and other partners with support from Head, TA Medical, Senior leads, TA Medical and/or Leads, TA Medical. The Lead, TA Medical or Associate, TA Medical is the key project representative to commercial and GDD within Japan, and to global medical outside of Japan.

【Major Accountabilities】
The Lead, TA Medical or Associate, TA Medical is accountable for all of the below items with support from Head, TA Medical, Senior leads, TA Medical and/or Leads, TA Medical.

• Bring clarity to the medical strategy and the tactics in the therapeutic area by their own medical/scientific knowledge/interpretation/judgement and deep understanding of external voice/environment as medical/scientific/clinical research expert.
o Develop outcome-focusing TA Medical strategy aligned with TA strategy from both local and global points of view
o Act as “Medical lead” in the agile project
o Drive the actionable insight cycle by giving regular clear direction to MSLs on activities, messaging, targets, etc., and utilize collected insights to further refine the medical tactics
o Work with PMO to shape the project work breakdown structure for the TA and to identify/secure required resources and budget of the teams
o Input local needs into global strategy and collaborate with global teams on global project
o Develop omnichannel engagement (OCE) plan by conducting omnichannel data analysis in collaboration with OCE capability pool and Medical Science group

• Lead/execute the evidence generation strategy in the responsible therapeutic areas as a medical/scientific/clinical research expert through scientific publications and innovative medical solutions in close collaboration with internal and external stakeholders.
o Plan/lead/execute primary data collection (PDC) and secondary use data (SUD) studies including retrospective researches, prospective researches, biomarker researches, translational researches, database studies, etc. in collaboration with ME&E Dept.
o Plan/execute Integrated Evidence generation Plan (IEP) by leading cross functional team

• Provide training for the organization he/she belongs to by leveraging highly advanced medical/scientific/clinical research expertise in the therapeutic area.

• Work as Patient Engagement Liaison (PEL).

■休日：完全週休二日制

■医薬品等安全性情報管理（臨床試験・市販後）のプロジェクトマネジメントと、そのサービスレベルの担保・維持を担います。 顧客窓口として、実働チームのオーバーサイトを通じ、顧客に対してシームレスで可視性の高いサービスを提供できるよう、安全性部門担当チームを統括・リードします。 さらに、グローバルチーム、および、提携企業と協力して、顧客とのパートナーシップを拡大し、関係を強化します。

・プロジェクト成果物を管理する。プロジェクトにおける日々の顧客対応をリードする。プロジェクト計画（タイムライン、成果物）、スコープ、品質、収益を管理する。（ 収益管理には、財務システムの更新、売上確認、請求、予算のレビュー、財務分析、チェンジオーダーの対応などを含む）
・KPI（売上、コスト、利益）をオーバーサイトし、財務面のパフォーマンスを担保する。
・アサインメントによっては、メディカル インフォーメーション(MI) チームのリーダーとして
　　- 業務手順・使用するシステムの構成と運用などにつき、クライアントとの間で、提案・協議・調整を行う。
　　- セーフティオペレーションチームと協働し、チームメンバーにトレーニングとメンタリングを行い、スキルレベルと生産性を向上する。
　　- チームのリソース調整、役割分担、進捗と品質の管理を行う。
・SOPや過去のベストプラクティスに基づき、プロジェクト開始時における潜在的リスクの特定や、稼働後リスク軽減策を実施する。
・内外の関係者との会議をリードする。プロジェクトステータスの情報更新や、プロジェクトの戦略を策定する。
・顧客とのパートナーシップを形成し、良好で強い関係を維持する。顧客のロイヤルティと契約更新を注視し、新しいビジネスチャンスを協議する

【Job Purpose】
・MSL Head is the field-based manager responsible for MSL team. It is expected not only leading the MSL team but also being an expert in scientific engagement with the background of a physician and/or a scientist with in-depth knowledge of not limited to ViiV medicines but the wide range of HIV infection relevant topics as the role model of MSLs.
・MSL Head drives MSL team by setting the right business objectives and priorities aligned with RDGM, MA Japan and the corporate counterparts to ensure the delivery of the medical plan and safe and effective use of ViiV products.
・MSL Head ensures the team to provide non-promotional scientific engagement with HCPs to ensure the HCPs’ right understandings on and the safe and appropriate use of ViiV products by planning and executing HCP engagement activities aligned with Medical/ company operational plan.
・MSL Head develops the capabilities of MSL to achieve world-class scientific engagement possible. For that purpose, MSL Head is expected to have high levels of coaching skills, medical/ pharmacological understandings and insight.
・MSL Head is expected, as an internal expert, to build robust relationship with external experts and internal/ external stakeholders.
・MSL Head collaborates with other functions to implement medical/ company plan effectively.

【Key Accountabilities/Responsibilities】
・The role of the MSL is inherently non-promotional and MSL Head is accountable for the MSL group and report into ViiV Japan CMD, underneath of ViiV RDGM.
・MSL head leads the MSL group to develop and implement the external engagement plan in accordance with the pre-defined medical strategy and medical plan.
・MSL Head helps to develop an effective Medical plan (and corporate plan as needed) and owns the operation of the Medical plan in collaborate with CMD and other key members.
・As the leader of ViiV Japan, MSL Head shows the leadership by coordinating and closely collaborating with other functions to bring the knowledge and insight obtained by all sorts of SE activities.
・MSL head is accountable for MSL performance and KPIs in line with ViiV global standard.
・MSL Head builds the team enables peer-to-peer scientific relationships with MSL audience HCP and healthcare organizations/scientific societies to address their information needs and gain insight that inform ViiV medical, commercial and research strategies.
・MSL Head exchanges scientific insight with external experts and internal stakeholders as an internal expert.
・MSL head evaluates the skills of MSL team members, detects areas for potential, defines the path for development, and provide necessary trainings.
・The role of the MSL Head is not limited to a manager of MSL but the role model of other MSL, by both teaching the skills of the engagement/ the knowledge on HIV and coaching on site.

■休日：完全週休二日制

業務内容

医学的・科学的見地に基づいたエビデンスの提示」と「KOLエンゲージメントの向上」により検査の価値を最大化し、販促戦略の構築と検査の普　 及に貢献をする事を 目指します。

　臨床研究に関する社内外の手続き（契約、倫理委員会等）、臨床研究モニタリング、DM、解析等を疾患担当と協働し臨床研究を円滑に開始し終　　了を目指す。

　派遣社員の方々と協働して仕事を進めていく中で、派遣社員に対する教育も担って頂きます。

■休日：完全週休二日制, 土, 日, 祝日

業務内容

　 循環器領域、内分泌・代謝領域、感染症領域、Critical Care領域、Oncology領域、Women's Health領域を網羅し活動します。

　「医学的・科学的見地に基づいたエビデンスの提示」と「KOLエンゲージメントの向上」により検査の価値を最大化し、販促戦略の構築と検査の普　　及に貢献をする事を 目指します。

医学専門家とのコミュニケーションを通じて、アンメットメディカルニーズを収集しロシュ製品の新たな価値の創造と臨床実装の促進・普及を　　関連部署と連携し進めます。

市販後を見据えた開発戦略（ビジネス戦略含む）の立案と実行により、適切なタイミングにて製品を上市、またMSL活動につなげることでビジ　　ネスに貢献する事を目指します。

■休日：完全週休二日制, 土, 日, 祝日

Job Profile Summary:
The Director of Operations serves as a key member of the agency leadership team and the primary champion of the agency’s practices and procedures to ensure the agency works as one. This individual is responsible for management of the operations team inclusive of direct supervision of the department managers, providing mentorship and developing succession plans for the operations employees. This position encompasses three key areas – practices and procedures, profitability, and staffing.

■休日：完全週休二日制, 祝日, 夏季休暇, 年末年始