外資製薬メーカー/Medical Affairs Senior Medical Advisor Infectious Diseases/Antibiotics/Antifungal/HIVの求人【バイオ転職ナビ】


Medical Affairs Senior Medical Advisor Infectious Diseases/Antibiotics/Antifungal/HIV 急募求人  /  外資製薬メーカー

職種 Medical Affairs Senior Medical Advisor Infectious Diseases/Antibiotics/Antifungal/HIV
社名 外資製薬メーカー
業務内容 <Role and Responsibilities>
・Under the direction of the Strategic Executive Director, perform following jobs:
- Prepare and implement country medical/scientific strategy (Country Medical Affairs Plan, CMAP)
- Align medical strategy with important internal stakeholders (Marketing, Development)
- Identify medical evidence needs and develop clinical study concepts to maximize the scientific value of products in line with the CMAP
- Review study protocols from scientific and strategic viewpoints
- Build and maintain good relations with important Scientific Leaders through highly-scientific interactions and peer-to-peer discussions
・In-house medical expert responsibilities
- Medical review of promotional materials
- Educate and inspire medical affairs team members to have high scientific standards
- Provide medical advice for commercial team training
- Be the central contact point for the global medical teams and other global stakeholders
- Present scientific content to top management and other stakeholders
求める経験 <Required>
・5-10 years of clinical experience in Japanese/foreign institution, with at least 3 years of formal training at major area in infectious diseases, e.g. Internal medicine such as virology, bacteriology, gastroenterology, ICU etc as a researcher or M.D.
・Profound scientific knowledge and ability to grasp scientific topics quickly and explain those in a logic and understandable manner
・Team player and Communicator with proactive, confident and positive personality
・In addition to the basic clinical knowledge/experience, have strong desire to learn new areas and have a flexible mindset
・Creative, innovative, solution-oriented strategist
・Well balanced judgement regarding compliance with highly ethical min
・ Ph.D, Certification of academic society or M.D.

語学力 英語力:中級
年収 1200万円 - 2000万円
雇用形態 正社員(期間の定めなし)











  • 人気企業(大手企業・優良企業)や人気業種
  • IPO要員や新規事業立ち上げなど重要度なポジション



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Regulatory Operations Associate

<Group Purpose> Facilitate patient access to Amgen products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise; interfacing with agencies on regulators; aligning with key cross-functional partners; integrating into Amgen’s commercialization process, and continuously improving our processes and developing our talent <Job Summary> Support the tactical execution and detailed deliverable to support Regulatory Activities including CTN, PMDA consultation, and NDA (eCTD) <Key Activities> *Oversight service providers for eCTD and/or e-Data *Execute preparation, compilation, and submission of regulatory dossiers according to Japanese requirements *Ensure the contents and format of dossiers conform to internal and external guidelines and regulations *Provide guidance to global teams on the structure of regional dossiers and eCTD Japan specific requirements *Document management *Responsible for ensuring quality control procedures for dossiers and components are in place and adhered to *Evaluate and ensure timely data entry for regulatory registration tracking system *Participate in the development and maintenance of policies, SOPs and associated documents for GRAAS Japan

Japan Development Team Lead for Immunology

・As a responsible person in assigned projects (immunology), demonstrates strong leadership to execute development plans aligned with therapeutic area strategy and timeline with high standard of quality. ・Engages and collaborates with global/alliance counterpart to align with global strategy as a representative of BMKK in assigned therapeutic area. ・Oversights team’s activities to ensure quality of execution. ・Provide input to senior leadership team for effective decision-making and execution. Based on the input and direction from manager, creates and ensures execution of the overall clinical development plan for an asset or assets in one or more tumor types. ・Solicits and integrates input from statistics, regulatory, outcomes research, medical, commercial and other experts. Ensures that studies are aligned with target label indications and commercial goals, and are properly designed and conducted in a timely and cost efficient manner. ・Oversees the review of safety and efficacy data across the program and integrates this information in order to detect relevant patterns and makes study modifications or start/stop recommendations as needed. Provides timely updates to manager in Japan and governance boards. ・Responsible for the creation of key study documents (e.g., integrated summaries of safety and efficacy). ・Initiates, develops and maintains key relationships with internal and external stakeholders. ・Selects, leads, develops, motivates and achieves results through teams. ・Provides Matrix leadership for integrated team of professionals who are accountable for all components of study design and execution. ・Oversees Phase 1 ・ Phase 2 studies ・Provides medical and scientific expertise to BMS colleagues in drug discovery, labeling, regulatory, outcomes research, and marketing/commercial departments. Provides scientific/medical input to, and reviews various study plans which are implemented by the Operations group. Advises creative solutions for operational obstacles. Provides medical/scientific perspective regarding pricing,reimbursement, quality of life, publications needed at launch, lifecycle management etc. in order to achieve the program’s commercial objectives.


【プロトコール作成から施設選定、海外での治験説明会参加、試験実施、当局査察対応まで含む幅広い臨床開発業務を担当します】 ■想定している担当領域は糖尿病の第三フェーズです。今後も成長ホルモンや肥満適応拡大を目指す薬剤など複数の開発計画があります。 ■モニター業務は、グローバルポリシーとして、CROはほとんど使わず、自社のCRAが行っています。迅速で的確な対応はドクターからの信頼も厚く、試験のスムーズな実施のみならず薬剤の信頼にもつながっています。 ■ご経験によりトライアルマネージャーなどに進む方もいます。 ※シニアCRAの方には、経験を活かした専門性の高いモニタリング活動およびCRAの指導も期待します。 【今後の開発計画】 開発中 第Ⅲ相臨床試験  ・糖尿病(1型および2型)  ・血友病A患者の出血治療及び出血予防  ・血友病B患者の出血治療及び出血予防  ・ヌーナン症候群における低身長  ・成人に対する成長ホルモン補充療法 ※国際共同治験においては、モニターミーティング、治験説明会、治験結果報告会等を海外で実施することも多く、海外出張の可能性がございます。