When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every
The Senior Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between
Responsibilities: • CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials. • Foster internal and external
Role Summary The clinician contributes towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region. The clinician may be required to design a
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every
Sr CRA II Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate
Sr CRA I Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate
CRA II Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change
Job Description 期待される役割と業務内容: 臨床開発プロジェクトの以下の業務の実行又はサポート 臨床開発戦略策定 早期開発戦略及び承認申請までの製剤開発を含む臨床薬理開発領域の戦略の考案 開発戦略に基づいた臨床薬理領域のPMDA相談資料の作成及び照会事項に対する回答作成 臨床薬理試験に関する以下の業務 治験実施計画書の作成 同意説明文書(案)の作成 治験実施計画書に関連する資料(症例報告書、関連手順書等)の作成、サポート及びレビュー 治験に必要な資料及び資材の準備やベンダー(国内外)との交渉 治験データのメディカルレビュー 治験総括報告書の作成(関係部署と協働) 承認申請に関する以下の業務 承認申請資料(CTD)の臨床薬理パートの作成 承認申請後の臨床薬理に関する照会事項に対する回答作成 必須条件: 医薬品臨床開発業務の経験(3年~15年程度) 社内(国内・外)関連部門及び外部機関との協働作業のためのコミュニケーションスキル 英語力(メール、電話及び会議で、米国本社及び海外ベンダーへの説明・説得及び情報聞き取りができる) 薬学又は生命科学に関する専門知識 望ましい条件: 臨床薬理開発業務の経験 治験実施計画書、CTD及び治験総括報告書作成、当局照会事項対応 CRA又はStudy management等業務の経験 今回の募集は、R2(Scientist)、R3(Sr. Scientist)または、R4(Associate Principal Scientist)での採用となる予定です。 応募の際にはカバーレターと応募書類(履歴書・職務経歴書)を添付してください。 Required Skills: Adaptability, Clinical Development,
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
Director IPH ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at
Sr. Site Management Associate ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion
Duties & Responsibilities: オンコロジー領域における外部顧客との医学的・科学的エンゲージメント活動を通じ,製品価値・患者アウトカムの最大化に貢献します。開発後期から疾患領域の専門家の先生方から,上市後の適正使用推進に役立てるinsightを得るScientific Interview / Scientific Exchange 活動を行います。また,特定の医師とのコミュニケーション,アドバイザリーボード会議,公表論文等から,自発的かつ継続的にプロダクトのアンメットメディカルニーズを探求する姿勢が求められます。得られたinsightを集約し,外部ステークホルダーとの協働を通じて,長期的な視点でメディカル活動・プロジェクト計画を立案できる人材を求めています。 Basic Purpose of the job 1 担当疾患領域におけるGBP (Global Brand Plan)/ICP (Integrated Customer Plan)に基づく科学的な課題をScientific Exchangeを通して解決し製品価値の最大化に貢献する。 To maximize product value through scientific exchange via achieving scientific objective in the
Job description: 1. Provide evaluation and certification services, or cybersecurity assessment services, for industrial products, industrial equipment, industrial components, machinery, control systems, and connected products. 2. Respond to customer inquiries regarding applicable standards and regulations. 3.
Job Overview: Site Navigators II plays a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point
Job Overview: Senior Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples