職務の目的および主な業務内容 Job Purpose & Key Responsibilities スペシャルティ領域での新薬の承認取得を通して、日本の患者さんにイノベイティブな治療を提供することに貢献できる業務です。 より難易度の高いプロジェクトや国内外ともにステークホルダーが多いプロジェクトにおいて以下を行う。 新薬開発及びライフサイクルマネジメントにおいて、薬事戦略を立案/実行する。 薬事関連規制や関連する事例等を考慮した薬事戦略を立案し、チームメンバーと協働して実行する。 承認申請や対面助言等、薬事関連業務をリードし、規制当局との交渉戦略を立案/実行する。 薬事的課題を分析し、適切な解決策を提案/実行する。 海外チームと良好な信頼関係を築き、薬事関連規制や薬事戦略の提供を実行する。 海外薬事規制等を踏まえた国内薬事規制の問題点を提示する。 規制当局と良好な信頼関係を築き、適切なコミュニケーションと薬事的交渉を実行する。 規制当局との交渉の場において議論内容をリードする。 ※職務内容および勤務地の変更範囲は会社の定めるところとする。 必要な条件Basic Qualification スキル Skill 薬機法の体系、開発・承認審査の概略に関する知識 プロジェクトチームや規制当局で開発薬事戦略を説明するコミュニケーション力 グローバルコミュニケーション力（英語での理論構築、読み・書き・会話力） 経験 Experience 医薬品等の新薬開発関連業務 学位/資格/語学力 Education/certification/Language 医学、薬学、生物学、科学等での学士もしくはそれと同等以上 望ましい条件 Preferred Qualification スキル Skill ロジカルシンキング
At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the world’s financial system, we touch nearly 20% of the world’s investable assets. Every day
Analyst, Regulatory Compliance Operations, Tokyo, Japan Role Responsibilities This position is responsible for supporting Western Union Japan KKs (WUJKK) regulatory compliance framework and ensuring adherence to applicable regulatory requirements, licensing obligations, and reporting requirements established by the Japan Financial
Job Description Senior Consultant Health Science (Product Stewardship/Regulatory Affairs) Plant Protection Team, Tokyo, Japan Inviting bright minds Do you want to push the boundaries of your profession and develop your excellence in an open, collaborative and empowering
Job Purpose The Clinical Scientist (CS) in Japan is responsible and accountable for clinical scientific outputs for assigned projects and studies in Japan. The CS will have accountability for approximately 2 - 4 projects (assets) at
Job Purpose The Clinical Development Lead (CDL) in Japan is the single point of accountability for all clinical development activities for assigned asset(s). The CDL provides scientific and medical leadership to define and deliver Japan clinical
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
Job Description Position Summary The Global Treasury Director will lead the company’s global treasury function, covering cash and liquidity management, funding, financial risk management, banking relationships, capital structure support, treasury governance, and insurance-related coordination. This role
Role Summary The Oncology Medical Science Liaison (MSL) is a field-based, non-promotional role supporting GSK’s clinical development activities in oncology in Japan. This position is focused on supporting ongoing and planned clinical trials through high-quality scientific
主な職務内容Key Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: ●Shape medical strategies that advance patient outcomes and strengthen GSK’s leadership in
Want to be a part of Asia Pacific & Middle Easts (APME) largest, most innovative, and rapidly growing data centre company? AirTrunk is a technology company with a powerful purpose - to scale and sustain the
We are seeking an experienced Senior Quality Assurance Manager to lead and maintain our local Quality Management System, ensuring compliance with local regulations and global CSL Behring standards. This role is responsible for driving quality excellence
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials
WPP is the trusted growth partner for the world’s leading brands. We unite cutting-edge media intelligence and data solutions, world-class creativity, next-generation production, transformative enterprise solutions and expert strategic counsel in a single company – powered
Job Description: Business Overview Mission Rakuten Groups basic management philosophy is to Empower people and society through innovation. We provide more than 70 diverse services, including EC services such as shopping malls and travel booking sites,
The Japan Compliance team is looking for an experienced Compliance Manager with experience in Japan Financial Services Agency (JFSA) regulations covering Prepaid Payment Instruments, and AML and ASF regulations. The Compliance Manager is responsible for providing AML,
Position SummaryThe associate director, Market Access & Healthcare Policy (MAHP) in Japan is responsible for monitoring healthcare system and regulatory environment affecting Alexions business and advancing Alexions business priority in the policy area through building, maintaining, and
Career CategoryClinical Job Description Purposes of the job are, Accountable for leading the development and implementation of the Japan Clinical Development Plan (JCDP) which is a part of Japan Evidence Generation Plan (JEGP), incorporating local current
Maersk Global Trade and Customs Consulting (GTCC) is the international trade and customs consulting arm of Maersk. We support clients in navigating the complexities of cross-border trade by optimizing customs compliance, leveraging duty-saving opportunities, and improving
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our