About Johnson & Johnson 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
About Johnson & Johnson 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
About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and
About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and
About Johnson & Johnson 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
About Johnson & Johnson 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
Johnson & Johnson Innovation, a part of Johnson & Johnsons Family of Companies, is currently recruiting for a Senior Manager / Associate Director, Early Innovation Partnering to be based in Tokyo, Japan. Johnson & Johnson (J&J)
About Johnson & Johnson 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
Position Purpose Develop and implement a business strategy for Janssen Japans introduction into the highly competitive Lung Cancer market with both short term and long-term business objectives Oversee and lead all marketing and sales plans to
Key Responsibility - Project Management for all project in the team. Make RA strategy for new product introduction to drive our business. - Take action to inquiry and/or instruction from Health Authority as a representative from Business
About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and
About Johnson & Johnson 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
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
About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and
Johnson & Johnson Innovation, a part of Johnson & Johnsons Family of Companies, is currently recruiting for a Senior Manager / Associate Director, Early Innovation Partnering to be based in Tokyo, Japan. Johnson & Johnson (J&J)
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring
Are you an experienced Engineering Supporter looking for a new challenge? Do you thrive in a cross-functional environment and enjoy implementing innovative solutions? If so, we have an exciting opportunity for you to join our team
Are you an experienced Production Engineer with a passion for driving continuous improvement and process automation? Are you ready to take on a new challenge in a global environment? We are looking for a talented Production
Are you an experienced Production Engineering Manager looking for a new challenge? Do you have a passion for driving operational excellence and leading a team? If so, we have an exciting opportunity for you to join
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 安全対策の検討と実行を主軸として、製品ライフサイクルを通して被験者・患者さんの安全性の確保に貢献する。 承認に向けてGSK Japanが遂行する開発プロジェクトを成功させるべく、クロスファンクショナルに活動する。治験において、治験参加者の安全を確保する試験計画を立て、得られた安全性データを適切に監視し、Global Safetyの方針に沿ったリスク対策を講じる。治験等で得られたデータに基づき、日本の医療環境を考慮したリスク管理を立案し、承認取得に貢献する。 承認取得後は、GSK Japanが承認取得した医薬品（Pharma製品、Vaccine製剤）及び医療機器を、医療従事者及び患者さんが常に安全・安心・適正に使用できるように、実臨床下で使用された際に得られる安全性情報及び関連する情報に基づき安全対策をGlobal Safety/Medicalチームと議論し立案・実行・効果検証を行う。また、臨床研究等Evidence generationにおいても参加者の安全確保に貢献する。 Human Subject Researchにおいて、患者の安全を考慮し、必要な安全性情報が得られるように臨床試験を計画し、得られた情報を安全対策に活用する。 治験薬概要書の作成 治験（試験）実施計画書、患者同意説明文書のレビュー Dear Investigator Letterなど重大なリスクへの対応 Global Safetyや国内関連部署と連携して申請資料を作成し、承認を取得するために照会事項に対してPMDAと協議する。 Global Safetyや関連部署との申請スケジュールの確認、協力要請 医薬品リスク管理計画（RMP）の作成（日本におけるリスク特定、資材の立案を含む）及び照会対応 電子添文の使用上の注意の作成及び照会対応 GCP適合性調査 GSK製品の安全対策の立案及び実施（リスクマネジメント）：上記評価・分析結果及び医療環境等の外部環境を勘案した、医療従事者及び／又は患者さん向けの安全対策を立案・実施し、その効果を検証する。 医薬品リスク管理計画（RMP：Risk Management Plan）の作成及び維持管理 市販直後調査［EPPV］の企画及び報告書の作成 医療従事者向け情報提供資材の作成、患者向け情報提供資材の作成 電子添文（使用上の注意）の改訂とお知らせ文書の作成 資材の提供等を含む安全対策の立案（必要に応じて医療従事者との面談含む）
