Company Description PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across
Job Description SummaryAs a CMC development specialist, enhance Japan’s CMC development strategy by offering scientific and technical support to global/local CMC development teams and other departments, while keeping up with the latest technological advancements. [Note] 1:
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
ROLE SUMMARY The Supply Chain Lead (SCL) is the Global Clinical Supply Chain (GCS) key point of contact for RU/BU customers., They are responsible for liaising with either Global Product Development (GPD) Study Team Managers or Medical
Job Description Summary-This is a universal job description meant to capture some of the primary duties of this role that are common across functions or divisions. It is not intended to represent all of the specific
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice Job Description Helping deliver life-changing therapies Our broad range of clinical development and analytical services enables Thermo Fisher Scientific customers to drive innovation and increase drug development productivity. Recognized for accelerating promising
The Medical Science Liaison (MSL) is a field-facing role whose main objectives are to: exhibit a high degree of scientific and clinical knowledge, i.e. a robust knowledge of diseases, vaccinology, product development, clinical trials exhibit a high degree of
サノフィのMSLチームとメディカルサイエンスリエゾンの使命は、データの普及を加速するために相互の科学的交流に従事する外部の専門家や意思決定者にとって、その分野で信頼できる科学パートナーになることです。サノフィのメディカルフィールドベースチームは、治療領域における当社製品の科学的および医学的価値の理解を深め、将来の医療革新を加速する最先端の科学的交流を今日もたらすことで、新たなインサイトを集めます。 The Medical Science Liaison (MSL) is field-facing role whose main objectives are to: ■ Be the trusted scientific partner to key external experts by conducting timely, appropriate and frequent scientific exchanges to enhance the understanding
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Cochlear is the global market leader in implant hearing solutions. Cochlears mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant
Head of Preclinical Development YOUR TASKS AND RESPONSIBILITIES: Oversee and support the following; Prepare the preclinical part of J-NDA and PAA dossiers (efficacy pharmacology, safety pharmacology, DMPK and toxicology) for successful registration of Bayer products in
We are Reckitt そのチカラを自由に使え。 今の自分を超えていけ。 FREE YOUR POWER. PROGRESS YOURSELF. Home to the worlds best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the
Work Flexibility: Hybrid or Onsite Basic purpose of role/Why the job exists: The Transport Product Engineer is responsible for the day to day product support and technical aspects of customer product enquiries. In partnership with the
Position Purpose: The Regulatory Strategy Group Manager is a key leadership position in Japan Regulatory Affairs (RA) who contributes to achieve organizational vision and goals aligning with the strategic objectives of Global Regulatory Affairs (GRA) and
JOB DESCRIPTION: Overview Responsible for the management/strategy of Regulatory Affairs (RA) activities in Japan (supporting all of Abbott Rapid Diagnostics), including Key Opinion Leader (KOL) Advisory Board development and management. Responsibilities Is a key member of the local
Job Description Summaryノバルティスのプロセス、規制および倫理的要件に準拠し、薬物動態、バイオマーカー、安全性等に関わる生体試料の収集に関して、臨床試験へ実装し、臨床試験開始から終了までのOperationを担当します。また、コンパニオン診断に関連する業務についてもサポートする場合があります。 Job Description Major Accountabilities Lead Clinical Biospecimen Scientist(CBS)の監督下、社内関係者と協働し、戦略に基づき、臨床試験における生体試料に関する技術面・Operationに関連する業務を実行する。主に以下の業務を実施する。 - 臨床試験関連文書（治験実施計画書や同意説明文書など）の臨床評価項目に情報を提供する。 - 臨床試験固有のサンプル収集表を作成する。また、ラボマニュアルなどの関連文書も含め、ラボキットの作成、サンプルの管理、検査会社（Laboratory）に対して技術的側面を管理する。 - 生体試料のライフサイクル全体を通じて、サンプル管理（処分含む）、輸送を担当する。社内関係者および検査解析会社（Laboratory）と協働し、症例報告書（CRF）とデータ転送に関する要件を定義し、 タイムリーな分析、転送されたデータの品質を担保する。 Risk management: 社内関係者と協力し、生体試料の収集および分析に関連する臨床試験固有のリスクおよび問題を適切に報告する。 Resource management: Lead CBSの監督の下、Vendor managerおよびProcurementと協力して、検査会社（Laboratory）からの提案、予算情報、および請求書の確認をおこなう。 担当臨床試験および担当プログラムにおいて、標準業務手順書（SOP）を遵守し、Lessen and Learnなどを通じて最良の結果を求める。 Key Performance Indicators GCP, SOP, ICH等の遵守 社内関係者、および臨床試験チームからインプットをもらい、期限内にサンプル輸送ができる体制を整える 。 担当臨床試験において、効率的な代替案およびリスク軽減計画を含む業務計画を策定し、生体試料関連業務の適時、効率的かつ高品質で実行する。 設定された期限内に、臨床試験固有の文書の作成またはサポートをする。
ジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。 Position Summary: The position is responsible for all the case processing and safety data management matters related to pharmacovigilance area activities for products both in development phase and in post-marketing phase. Primary roles & responsibilities include,
General Information Job Advert Title: Director, Clinical Pharmacology Location: Nihonbashi, Tokyo Division: Oncology Development Employment Class: Permanent Description 【募集の背景 / Purpose & Scope】 •Have ultimate responsibility and accountability for clinical pharmacology from first-in human through approval, including post-marketing
General Information Job Advert Title: Clinical Trial Associate (CTA) Location: Tokyo HQ (Nihonbashi) Division: Clinical Operations Employment Class: Permanent Description 【募集の背景 / Purpose & Scope】 In Clinical Operations Oncology, we work with domestic and international co-development partners and overseas team
General Information Job Advert Title: Global Translational Bioinformatics Lead Location: Nihonbashi,Tokyo Division: Early Development Employment Class: Permanent Description 【募集の背景 / Purpose & Scope】 Responsible for providing bioinformatics expertise to drug target selection, translational research, patient selection
