薬事、メディカルライティング/東京23区の転職求人一覧

As a Pricing Specialist, you will be in charge of executing market access and strategic pricing projects, including developing price negotiation strategies, initiating innovative approaches for timely price listing, working on pipeline access plans and mid/long term price forecasts, Wholesaler Purchase Price (WPP)/Average Realized Price (ARP) strategy, and Health Economic and Outcome Research (HEOR) activities. Additionally, the position requires close collaboration with internal and external stakeholders, as well as flexible support for achieving team goals and the company in Japan purposes, in close communication and relationship-building with both internal and external stakeholders.- Develop and execute price negotiation strategies, collaborating with pricing team members under the Group Manager's direction.- Contribute to pipeline access plans and mid/long-term price forecasts in the designated disease area, supporting CMR and financial

ResponsibilitiesDevelop strategic NHI pricing strategies and gain endorsement of NHI pricing strategies and proposals of NHI prices with Country President and TA Leads through the Pricing CommitteeDevelop robust pricing dossiers and strategically manage price negotiationsBuild strong alignment & partnership among Japan Pricing Core members (New Asset & Access Strategy team, New Asset Analysis team, DJ, Medical, Launch Excellence Team, Policy and Public Affairs, and the global PHI) to ensure optimal price settingDevelop Pricing-related OP assumptionsRefresh pricing assumptions and estimated prices for pipeline products and BD assets to reflect the latest competitive environmentMinimize the downward price adjustment by price revision/repricing through cross-functional collaborationMaintain good relationship with “Policy Planning Division for Pharmaceutical Industry Promotion and Medical Information Management, MHLW” (former EAD) and act as a m

Key Responsibilities:• Develop Japan health economics and HTA strategies for pipeline products that may be designated for HTA by C2H.• Oversee the development of submissions and manage the entire submission process for C2H Project management: Select, manage, and support relevant market access agencies to prepare and write HTA submissions and ensure the delivery of quality outputs on time. Effectively communicates status of projects to management and key business partners to keep them informed of project status, budget implications, etc.• Partner with the Global/International Value, Evidence and Outcomes (VEO) function in the development and review of health economic models and associated deliverables (model reports, SLRs, ITCs etc) to ensure they are suitable for the Japan HTA environment.• Represent the Health economics case and respond to queries at C2H expert organization meeting and post-submission questions• Review and monitor competito

•日本の規制およびガイドラインの調査と解釈•日本における体外診断用医薬品・医療機器の承認申請、登録、メンテナンスに関する業務•IVD製品変更プロセスの管理において薬事部門を代表する•必要に応じ、オペレーション、開発、その他の部門とのプロジェクトにおける部門間チームにおいて薬事部門を代表する•薬事部門を代表して、規制当局とのコミュニケーションやミーティングを主導する•国際登録チームおよびデータセンターと連携し、登録書類および情報を管理する•申請戦略、登録書類および情報の準備のための他社（製薬パートナーなど）または組織（サードパーティのRAコンサルタントなど）との協働•薬事部門を代表し、必要に応じて業界団体を担当または関与する•規制リスクを高める可能性のある問題の特定と、そのようなリスクに対処するための戦略の提案を実施する•臨床プロトコール、研究開発プロトコール、その他の会社文書（該当する場合、添付文書やマーケティング資料を含む）の規制当局への影響や問題の評価•部門メンバーのマネジメント、予算管理

Mandatory1. General Marketing Compliance Officer (SOKATSU-SEKININSHA)Responsible to assure compliance with GVP and GQP through supervision and instruction to safety manager and quality assurance manager. Must report issues and risks to the MAH.・Is the contact person dealing with the authorities for RA in Japan.・Checks the legal and regulatory compliance as well as the scientific content of the documentation sent by the Corporate RA department. ・Submits variations, renewals or new marketing authorization applications to competent authority. Attaches any relevant documentation according to the local requirements. ・Is in charge of the follow-up of the pending approvals. Answers questions and provides additional documentation when requested by the authority. Informs the Corporate RA department about the approval status of the dossiers. ・Is in charge of the local regulatory intelligence. Informs the Corporate RA department about new regulations

Responsibilities・Develop strategic NHI pricing strategies and gain endorsement of NHI pricing strategies and proposals of NHI prices with Country President and TA Leads through the Pricing Committee・Develop robust pricing dossiers and strategically manage price negotiations・Build strong alignment & partnership among Japan Pricing Core members (New Asset & Access Strategy team, New Asset Analysis team, DJ, Medical, Launch Excellence Team, Policy and Public Affairs, and the global PHI) to ensure optimal price setting・Develop Pricing-related OP assumptions・Refresh pricing assumptions and estimated prices for pipeline products and BD assets to reflect the latest competitive environment・Minimize the downward price adjustment by price revision/repricing through cross-functional collaboration・Maintain good relationship with “Policy Planning Division for Pharmaceutical Industry Promotion and Medical Information Management, MHLW” (former EAD) and act

Job Description Support execution and implementation of Regulatory strategies, including adhering to project timelines and prioritizing deliverables.Responsible for generating and delivering documentation for life cycle management and registration of products domestically.Coordinates the assessment of product changes to capture any impact on existing or in-process product registrations and letters to file.Coordinates and documents regulatory activities for clinical studies as needed.Assist in submission activities for new product approvals and maintenance of on-market products, and may include support for pre-submissions, Premarket approvals (PMAs), Conformity assessments, IDE submission, Annual Reports, Export certificates, etc.Ability to negotiate with PMDA/MHLW to bring submission/approval effectively.Ability to work in a fast-paced environment and maintain a “focused urgency” as specific events require.Ability to work cross-functionally

Key ResponsibilitiesPricing:As the Pricing lead for select inline brands and pipeline assets, work with internal partners and external stakeholders to establish and maintain optimal pricing and value of medicines.• Develop, lead and execute new drug price strategy as part of a broader Integrated Access Strategy including NHI drug price applications• In collaboration with Value, Access and Pricing (VAP) teams, co-develop and support execution of the broader Integrated Access Strategy (inclusive of new drug Value Proposition, access risks and mitigations, Health Technology Assessment, and value communication)• Collaborate with other departments (Medical, Business Unit, Regulatory and Development etc.) proactively to develop and execute value proposition• Respond to drug price revisions and repricing of listed products• Collect and communicate information on medical insurance system, drug price system reform, etc. to internal stakeholders• Brid

募集するポジションの主たる業務は、日本での事業を展開しているビジネスユニットで取り扱われる製品（クラスI～IV）に関して、次に掲げるものが含まれます。 ・日本国内への新製品導入や適応拡大などの薬事申請 ・既存製品の変更管理等を含む維持活動 ・海外製造元、ビジネス部門、臨床部門、品質管理部門等の社内ステークホルダーや社外パートナーと協業し、PMDAなどとの交渉を成功に導く。これによって承認取得から保険適用、製品発売、市販後の社内外のプロセスを完遂する

Roles & responsibilitiesPlay following roles and take responsibilities at each phase in the life cycle of the XXXX asset;Development stage:Provide appropriate input from a regulatory perspective to the new drug development plan, and thereby contribute to prepare an appropriate development plan.Contribute the development team in order to ensure that the J-HAs (PMDA, MHLW) accept clinical study plans and the clinical studies are initiated as planned.Decide whether J-HA interactions (PMDA consultation, Preliminary meeting etc.) are needed. When it is decided that a J-HA interaction is needed, prepare a consultation strategy to ensure that the proposed development plan is accepted by the J-HA.Identify the regulatory risks and notify all relevant colleagues of these risks, and propose risk minimization or mitigation plans and discuss them with relevant personnel in a timely fashion.Provide appropriate advice to ensure that query responses related

Position ResponsibilitiesAccountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs within the asset and/or indicationAccountable for the design, execution, and analyses of each studyAccountable for clinical content for CSRs and regulatory documents (e.g., briefing books submission documents and regulatory responses)Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conductRepresents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development functionProvides clinical leadership and disease area expertise into integrated disease area strategiesCollaborate and serve as primary liaison between external partners for scientific adviceServes as Primary Clinical Representative in Regulatory inter