外資製薬メーカー/Medical Science Liaison - Hematologyの求人【バイオ転職ナビ】

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Medical Science Liaison - Hematology 急募求人  /  外資製薬メーカー

ジョブNo.NJB1028946
職種 Medical Science Liaison - Hematology
社名 外資製薬メーカー
業務内容 MSL provides field-based medical / scientific expertise ensuring understanding of the disease area and our products as appropriate. They are integral to building valued constructive partnerships with key stakeholders in the medical community and the healthcare system. MSLs contribute to company success through both internal and external medical education and medical / scientific information exchange and support. MSLs utilize their medical / scientific expertise to gather medical insights and to support research/ data generation initiatives. Accountability Descriptions: 1. HCP Engagement ・ Reactively provide complex medical / scientific information to HCPs: this can include information included and not included in the label as appropriate as well as information on investigational compounds ・ Proactively educate KOLs and clinicians at staff meetings on important scientific / medical information on approved products and on disease areas ・ Manage scientific needs of KOLs by establishing long-term strategic relationships with key, influential physicians / investigators, major medical associations and academia to build outstanding product awareness and advocacy ・ Identify the medical gap through the communication with KOLs ・ Respond to unsolicited HCP requests (non-KOLs) ・ Provide Advisory Board support (advisor selection, faculty selection / preparation, presentation / facilitation ) ・ Gather (unmet) medical needs to inform pipeline development 2. Medical Research ・ Be involved in the support and coordination of Investigator Initiated Trials (IITs) Liaise with authors of publications 3. Congress and Meeting Support ・ Conduct medical presentations to KOLs / HCPs at scientific / medical / professional meetings and hospitals ・ Attend conferences, staffs booths and communicates insights to wider our organization 4. Appropriate Preparation ・ Ensure that they are fully prepared for each HCP interaction ・ Support and manage the external speaker at scientific / medical meetings 5. Medical / Scientific resource within us ・ Conduct medical / scientific trainings for ABM ・ Develop a working knowledge of the regulatory environment (support market access teams e.g., in compiling of dossiers) ・ Develop scientific knowledge to learn the latest intelligence through the domestic congress and Publications ・ Conduct administrative topics related to medical field-activities including medical material development
求める経験 *Qualifications - Min 2+ years experience in one of the therapeutic areasHematology from: o Medical Affairs (pharmaceutical industry or CRO) OR o the pharmaceutical industry OR o Medical studies - Prior experience of clinical trials management and understanding of GCP - Understanding of health economics - Technical knowledge in Neurology, Immunology/Dermatology and/or Hematology - Proven expertise in working with and within local regulations and code of practice *Education BSc; Advanced terminal degree preferred (MD, PhD, PharmD, DNP in medical specialty) or equivalent combination of experience and education
語学力 英語力:中級
勤務地
東京都
年収 700万円 - 1200万円
雇用形態 正社員(期間の定めなし)

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甲賀GQPスタッフ(LLP担当)

**武田薬品の長期収載品(LLP)を担当して頂きます** 医薬品並びに医療機器の製造販売業における品質保証業務(GQP)について、所属グループの計画を策定して遂行する。 ・国内外の製造所の管理監督(市場出荷判定の委託、取決め、監査など) ・変更、逸脱、苦情などの品質情報の処理、品質不良等の重大な品質トラブルの問題解決と措置(自主回収等) ・行政査察の対応(業許可更新等のGQP査察、海外製造所のGMP適合性調査の同行) ・品質システムの構築(国内レギュレーションとグローバルのポリシーと基準書に基づく体制の構築とSOPの制定) ・製品ライフサイクルを通した品質保証の構築 ・教育プログラムの充実と人材育成

MSL(ニューロロジーまたは炎症・免疫領域)

-KOLマネージメント(外勤ベース) -医学的、科学的見識に基づいた情報の提供と収集 -メディカルプランの作成と実行 -研究者主導試験のサポート

Clinical Programs Lead LOC

<Summary> This section focuses on the main purpose of the job in one to four sentences. -The primary responsibility is to be the lead for all Local Country (LOC) study activities ( in JP PMS activities led by the GPSP person are out of scope) ) in Japan. This role in Japan is expected to oversee study activities related to global programs which JP joins (regardless international or local stand-alone study) and contribute to the global dossier.This role should contribute to the understanding of the JP needs and feed this information to the global CPM.The role holder assures the country Medical Affairs plans are visible to the global CD and CDO groups in a timely manner.The position holder is expected to drive communication between the local and global functions, guide on required processes and structure if there is a special need for a role, assure alignment with the compound/development and outsourcing strategy, support oversight of the selected vendor, drive appropriate quality of the local studies and work in closest collaboration with the global Program CDO representative aligned with the predefined RACI by giving input onto R&R for each study. -Close collaboration and communication between stakeholders i.e. Drug Safety and Risk Management , Regulatory Affairs, MA, Patient Outcome, Clinical Development, Clinical Quality, External Partnerships and the CDO functions is expected. -In Japan the role holder should support local RA with input into the development activities as needed, especially for JP stand-alone studies and support communication with the global teams. This is a focus of this role. -Dependent on the stage of the life cycle of a compound the scope of oversight (of study and strategy) and interactions may vary. <Essential Duties and Responsibilities> This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. ・Represent Clinical Development Operations (biostatistics, data management, clinical operations, and clinical scientific writing, outsourcing) on brand planning meetings and respective CD activities to support realistic budget, time, allocations. ・Assure full transparency of local studies to the global organization and work closely with the respective global functions. ・Works collaboratively with the GPSP representative and global program lead ・Provides input to ……(以下詳細は面談時にご案内します)

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