Job Description 職務内容 クリニカルリサーチ領域での開発品の本邦臨床開発に係る以下の業務を担当する グローバル開発戦略における本邦臨床開発計画の立案・作成 本邦で実施する治験の科学的側面からのリード 臨床開発に係るPMDA相談準備・資料の作成 実施計画書の立案・作成(米国本社等、ステークホルダーへの説明・交渉を含む) ローカル試験:試験骨子から作成 グローバル試験:日本で実施するために計画書を適性化 他の治験関連資料(同意説明文書案、症例報告書、関連手順書等)の作成(他部門と協働) 治験実施のサポート(オペレーション部門と協働) 治験データのメディカルモニタリング 治験総括報告書の作成(メディカルライターと協働) 承認審査における臨床関連パートのリード 承認申請資料(CTD)臨床関連パートの作成(メディカルライターと協働) 臨床関連照会事項に対する回答作成 治験に関する学会発表及び/又は論文作成・サポート 必要とする資質 以下の業務を含む、製薬企業における臨床開発経験(5年以上) 臨床試験の運用経験(グローバル試験、ローカル試験、アジアン試験等) 臨床試験関連資料の作成・レビュー経験(治験実施計画書、同意説明文書等) 医学、薬学、公衆衛生学又は生命科学に関する学位(6年制学士又は修士以上) 未経験分野にチャレンジするフロンティア精神とリーダーシップ 国内外のチームメンバー及び社内外のステークホルダーと密接に協働するためのソフトスキル TOEICスコア730点以上に相当する英語力 Current Employees apply HERE Current Contingent Workers apply HERE Secondary
This role required candidate to permanently relocate at Jubail or Riyadh, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabias oil-rich region, this multinational corporation has solidified its position as a global
This role required candidate to permanently relocate at Jubail, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabias oil-rich region, this multinational corporation has solidified its position as a global leader in
Job Title CT Clinical Scientist Job Description Job title: CT Clinical Scientist Key Areas of Responsibility 1.Identify and connect new customer needs, solutions and technologies to initiate new methods (or disruptive enabling technologies) of diagnosis, treatment and/or care
Job Description Summary -Provide timely & professional ongoing Mgmt of Data Mgmt/Coding/CDDRA-Database Development/DAP deliverables and of clinical trial data with respect to cost, quality and timelines for all assigned trials within Clinical Data Mgmt. Ensure consistently
Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring
Job Description Summary: We offer cutting-edge research services and deliver valuable data acquired from experiments conducted in our pioneering laboratory in Showajima, Ota-ku, Tokyo! Our experiments cater to the needs of prestigious pharmaceutical companies, esteemed research institutes, and
This role required candidate to permanently relocate at Riyadh, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabias oil-rich region, this multinational corporation has solidified its position as a global leader in
This role required candidate to permanently relocate at Jubail, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabias oil-rich region, this multinational corporation has solidified its position as a global leader in
This role required candidate to permanently relocate at Jubail, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabias oil-rich region, this multinational corporation has solidified its position as a global leader in
This role required candidate to permanently relocate at Riyadh, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabias oil-rich region, this multinational corporation has solidified its position as a global leader in
This role required candidate to permanently relocate at Riyadh, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabias oil-rich region, this multinational corporation has solidified its position as a global leader in
This role required candidate to permanently relocate at Jubail, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabias oil-rich region, this multinational corporation has solidified its position as a global leader in
This role required candidate to permanently relocate at Riyadh, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabias oil-rich region, this multinational corporation has solidified its position as a global leader in
Company Description Since we opened our doors in 2009, the world of commerce has evolved immensely, and so has Square. After enabling anyone to take payments and never miss a sale, we saw sellers stymied by
About Recursive As the worlds population grows, we are facing a number of global challenges in the realms of environmental conservation, societal equity and ensuring that nobody is left behind in the transition to a digital
About Recursive As the worlds population grows, we are facing a number of global challenges in the realms of environmental conservation, societal equity and ensuring that nobody is left behind in the transition to a digital
Company Description Renesas is one of the top global semiconductor companies in the world. We strive to develop a safer, healthier, greener, and smarter world, and our goal is to make every endpoint intelligent by offering
Company Description Renesas is one of the top global semiconductor companies in the world. We strive to develop a safer, healthier, greener, and smarter world, and our goal is to make every endpoint intelligent by offering
About Recursive As the worlds population grows, we are facing a number of global challenges in the realms of environmental conservation, societal equity and ensuring that nobody is left behind in the transition to a digital