Calling all innovators – find your future at Fiserv. We’re Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We connect financial institutions, corporations,
Calling all innovators – find your future at Fiserv. We’re Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We connect financial institutions, corporations,
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
Calling all innovators – find your future at Fiserv. We’re Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We connect financial institutions, corporations,
Calling all innovators – find your future at Fiserv. We’re Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We connect financial institutions, corporations,
Calling all innovators – find your future at Fiserv. We’re Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We connect financial institutions, corporations,
Calling all innovators – find your future at Fiserv. We’re Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world. We connect financial institutions, corporations,
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,
Role purpose Provide high-impact, confidential executive support to the Japan CEO and Head of Banking. The role ensures the smooth running of day-to-day priorities through proactive diary management, stakeholder coordination (internal and external), travel and logistics
JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you
3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here,
Job Description: Business Overview Rakuten Group provides innovative services in the telecommunications and IT industries, aiming for growth in the global market. In recent years, we have been expanding our services for corporate clients, providing DX
Job Description: Rakuten Business Overview: Rakuten Group aims for growth in the global market by providing innovative services in the telecommunications and IT industries. In recent years, we have been expanding our corporate services, offering DX
Company Description Bosch Rexroth is a global leader in drive and control technologies, delivering innovative solutions that power everything from industrial automation and mobile machinery to factory and renewable energy applications. As part of the Bosch
企業概要 Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes that improve people’s lives.
企業概要 Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes that improve people’s lives.
Company Description The history of Bosch is the history of car evolution. As a top-class automotive equipment supplier, Bosch Corporation supports market expansion/inroads domestically as well as globally. Bosch will continue to pursue forward-looking technologies such
Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North
Company Description Wise is a global technology company, building the best way to move and manage the world’s money. Min fees. Max ease. Full speed. Whether people and businesses are sending money to another country, spending
企業概要 アコーは世界で約5700軒以上のホテルを展開し、ホスピタリティー産業においてヨーロッパではリーダー的存在です。現在日本国内では、Mギャラリーコレクション、プルマン、スイスホテル、グランドメルキュール、ノボテル、グランドメルキュール、メルキュール、イビス、イビススタイルズ、イビスバジェットの各ブランド計43軒を展開しております。 Accor operates over 5,700 hotels worldwide and is a leader in the hospitality industry in Europe. Currently, in Japan, Accor operates a total of 43 hotels under the following brands: MGallery Collection, Pullman, Swissotel,