The Team Lead, Global Regulatory Affairs CMC - Japan is responsible for providing strategic leadership and operational oversight for the Global Regulatory Affairs CMC - Japan team. Reporting to the Head of Global Regulatory Affairs CMC you will partner
Career CategorySales & Marketing Operations Job Description Job Description BA＆I aims to become an engine of change for the entire commercial organization to provide the highest level of customer excellence, embodying the idea of To Serve
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
Work Flexibility: Hybrid or Onsite Key Areas of Responsibility: Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature
About the Role: This role is responsible for ensuring compliance with Ferrero Group quality requirements across the entire product value chain, from plant to consumer. The position focuses on implementing, monitoring, and continuously improving quality activities
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
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
Basic purpose of the job: Serve as a key strategic business partner to the assigned TAs through forecasting and business analytics to drive strategic decision making of the TA and ultimately help the business deliver profitability
Moon is hiring a Director of Finance and Accounting, who will be responsible for leading the Finance function for Moon Creative Lab at both our Palo Alto, California and Tokyo, Japan studios. The Director of Finance
Role Purpose: To strengthen execution capability within the brand team and ensure high-quality and timely delivery of key marketing initiatives. Key Responsibilities: Lead end-to-end execution of marketing initiatives (promotional materials, digital content, campaigns) Plan and execute
Principal Biostatistician / Programmer Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our
Who we are looking for This position would report to Tokyo Foreign Exchange Head of Sales. Responsibility to focus on functions to expand sales business in Japan, support business activities in the team and cooperate with
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
This is what you will do: The Associate Director, Data Steward plays a central role in maximizing the value of organizational data and establishing a highly reliable data utilization environment. This position will closely collaborate with
ispace is looking for RF Communications Engineer to join our Avionics Team. In this role, you will own and design the RF communications subsystem architecture and analysis efforts for ispace’s lunar lander current and future development projects,
Job Purpose and Impact BAND DESCRIPTION Supervises established and seasoned professionals and may also supervise support level employees. Sets goals and objectives for team members for achievement of operational results. May focus on policy and strategy
Job Description ・医薬品開発戦略に対して、臨床薬理/ファーマコメトリクスを活用した提案を行い、早期承認に貢献する ・他チームや臨床現場に対して、治験薬の臨床薬理学的情報を的確に提供するとともに、問題解決を行う ・プロトコールの試験デザイン・被験者数・解析方法並びに試料のサンプリングポイントなどを検討し、適切な提案を行う ・薬物動態（PK）解析を実施し、治験総括報告書の該当するセクションを作成する ・PK結果の速報を作成し配信する。 ・臨床現場に提供すべき治験薬の臨床薬理/薬物動態学的情報を精査し、非臨床ADMEを含む申請資料の臨床薬理関連部分に過不足無く盛り込む ・臨床現場に提供すべき治験薬の臨床薬理/薬物動態学的情報や用法・用量に関連する臨床薬理領域の電子データを特定し、戦略に応じて、適切に提出する ・PMDA相談の資料作成・当日の議論に臨床薬理担当者として加わり、承認に貢献する ・本社の担当者と継続的に連絡を取りながらこれらの業務を進める。 ・必要に応じてモデリング＆シミュレーション（M＆S）を実施する ・グループ内のM&Sスキル向上への提言及び下位部員に対するメンターとして教育・指導的役割を担う 応募条件 【必須（MUST）】 ・臨床薬理部門もしくは関連部門での3年～10年程度の実務経験 ・M＆S（population PK, PK－PDまたはExposure－Response解析）の知識・理解 ・非臨床ADMEの知識・理解 ・ノンコンパートメントPK解析の知識・理解 【歓迎（WANT）】 ・ノンコンパートメントPK解析の実務経験 ・M＆S（population PK, PK－PDまたはExposure－Response解析）の実務経験 ・各品目のプロジェクトチーム内で、他のメンバーと積極的に関わって議論/プレゼンできる方 ・海外の担当者とのメール、電話等でのコミュニケーションが可能で、関係を構築できる方 ・CDISC / non－CDISCの電子データ申請に関する基礎知識・経験があれば尚可 ・博士号（PhD）であれば尚可 Required Skills: Clinical Trial
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are,
About The Opportunity We are seeking experienced healthcare and social assistance professionals to contribute to a cutting-edge AI benchmarking project in the target language. As a Subject Matter Expert, you will help create and review realistic
About The Opportunity We are seeking experienced professionals in Finance and Financial Services to contribute to a cutting-edge AI benchmarking project in the target language. As a Subject Matter Expert, you will create and review high-quality,