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(Medical Doctor)Medical Manager: medical affairs 急募求人  /  大手製薬メーカー

ジョブNo.NJB1014592
職種 (Medical Doctor)Medical Manager: medical affairs
社名 大手製薬メーカー
業務内容 <Core Job/Overview>
To maximize product portfolio through the development of a Medical Strategy aligned with Local Brand Team and Corporate Medico-Marketing Objectives
<Job / Detail>
1.To ensure an accurate Medical Gap Analysis which allowed identification of the unmet Medical and Business Needs and its integration in the Brand Strategy
・Via close interaction/discussion with KTL
・Through an accurate analysis of existing literature
・By building an ad-hoc plan for Advisory Boards
・As appropriate, via surveys/observational studies
2.To ensure that the Study-Plan appropriately covers the identified Unmet Medical Needs and is consistent with Brand’s priorities (Local/Global)
・To assess the relevance of Japan’s participation into Global studies and, as appropriate, to ensure Japanese patients be enrolled
・In close coordination with other Departments, to define the post-marketing clinical program: disease registries, PMS, other observational and interventional studies
3.To define the medical communication plan and ensure its timely implementation in compliance with Local and Global regulation/SOP. Leverage the Brands through a fair/transparent communication of study results
・To leverage the key results in most relevant Congress and Journals - Support the authors/presenters as required
・To ensure study results are fairly mirrored in the promotional material and complies with ethical guidelines/SOPs
4.To established a trusted partnership with KTLs, HCP and patient-associations
・To identify main stakeholders involved in the management of patients.
・To timely assess IST proposal(s) in terms of scientific interest and compliance to GCP/Ethical Guidelines. To evaluate its synergy/consistency with the Brand Strategy
5.To develop a proactive interaction with cross-functional functions
・MSL activities: to define and lead the MSL plan and ensure it is appropriately cascaded to region
・To proactively participate to relevant cross-functional team meeting (MKT, PMS, etc..)
求める経験 (Experience / Mandatory)
・Leadership,
・Strategic thinking
・High communication skill both in English and Japanese.
・MD
・At least 3 years past-experience in Medical Affairs
(Experience / Desirable)
・Clinical expertise in one of below area: diabetes, cardiovascular diseases, oncology, Immunology
・Previous Pharma experience
・Education/research background in biostatistics and/or epidemiology

語学力 英語力:中級
勤務地
東京都
年収 1400万円 - 2000万円
雇用形態 正社員(期間の定めなし)

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Product Manager_Bone

<Main purpose of Job> Marketing Manager position leading bone osteoporosis access marketing initiatives and programs for romosozumab. Candidates must have a proven track record of sales success and/or marketing experience developing and implementing a wide range of high-impact marketing tools and programs. <Responsibilities> Contributes Japanese Brand Plan development Manages the relationships with co-promotion partners to maximize the value of co-promotion scheme Develops and executes sales promotional activities in alignment with co-promotion partners Coordinates and leads meetings with co-promotion partners Engages and involves sales leadership in planning and key initiatives Develops programs and tools for optimal sales force effectiveness Partners with the Medical Communication Manager in the development and execution of the Medical Affairs and Promotional Program Establishes regular contacts with key opinion leaders Develops regional congress plans Collaborates with colleagues in other Expansion Markets and corporate office as needed on joint projects.

Study Manager, Clinical Operations (炎症・免疫)

<Summary/Scope> The Study Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, JGCP, Regulatory Authorities’regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include operational direction of one or more cross-functional Japan study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO). Study manager has full responsibilities for studies led by the Japan Study Team. Responsibilities in the global study is complied with Affiliate Involvement Model (AIM), Job aid and direction given by Global Clinical Trial Manager (CTM). Responsibilities involve a combination of execution and oversight-dependent on the sourcing model - to ensure deliverables and may include, but are not limited to, the following: -Financial Planning and Management ・Strong understanding of the cost drivers, attuned to principles of cost disciplined science and are able to proactively manage the study budget ・Takes ownership and accountability for the development/management/reconciliation of overall study budget(s) ・Development/management of vendor scope of work (SOW) per contract, quality, and budget ・Review/approval of vendor invoices and management of accruals and SOW changes ・Review/approval of site invoices and management of site budget -Project Management ・Drive study execution ・Oversight of clinical monitoring quality and adherence to established processes and plans ・Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders using data and strong inter-personal influencing skills to make robust data driven decisions ・Proactive identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs. ・Maintenance/updating of data as appropriate in project management tools including CTMS ・Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation -Study Planning and Conduct ・Facilitation of site feasibility/selection processes with use of robust data ・Operational and strategic input into study documents such ……(以下詳細は面談時にご案内します)

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<担当する仕事内容の詳細> ・承認申請書類、届出書類等の薬事監査 ・GVP、GQP自己点検 ・製造販売中止製品の承認整理、後発医薬品の薬価基準収載手続き及び削除 ・薬事規制の対象となる添付文書、製品のパッケージ、広告等の監査 ・薬事規制に係る情報等の収集・分析及び関係部署への情報提供 ・薬事に係る相談と助言等

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