( 概要 ) 日本国内で治験を実施するためのオペレーションチームリーダーとして,国内外のステークホルダーとの協議•交渉など,エキスパートとしてのコミュニケーションを通じ,品質を確保した臨床試験を計画通りに遂行する。 ( 具体的な業務例 ) •試験実施施設の選定戦略,症例組み入れプラン•戦略の作成及び実行 •試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 •試験全体の進捗および GCP , SOP に沿った臨床試験の実施と品質の確保 •国際共同試験の場合,海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション •試験における Risk & Issue Management •治験契約締結交渉,データ固定, GCP • SOP に基づくモニタリングに対するモニターへのフォロー •チームビルディング,ステークホルダーマネジメントによるチーム作り •社内の改善活動 / Task force team への参加 •試験全体の予算の管理 Position Summary: The
Job Description Summary -Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system.
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
■ 職務内容 / Job Description Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site in
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
Görev Tanımı The Position Individual contributor is accountable for ensuring all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution
Job Description Summary Enable and drive ethical business conduct through effective implementation of the ERC program (Local training, Disseminate policy/guidelines, remediation, and communication). And continuously seek opportunities to simplify NPKK’s rules and SOPs to support principles-based
Job Description Summary Provide leadership, planning and technical support for the introduction of processes for new product development and existing manufacturing. Implement efforts to improve product and process quality. AME (Advanced Manufacturing Engineering) is recognized as
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
Job Description Summary Role Purpose: The Lead, TA Medical or Associate, TA Medical is accountable for building responsible brand or disease area medical strategy and ensuring its execution in collaboration with MSLs, MSEs and other partners
■ 職務内容 / Job Description Drive development and execution of external communications strategy to drive a corporate reputation and advance science and therapeutic area leadership of AZKK. Leads a team of external communication managers and specialists
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 職務の目的 The Japan Medicine Development Lead (J-MDL) is accountable for a medicine development in Japan to ensure delivery differentiated medicines of value for patients, stakeholders and markets in Japan. The
Job Description Summary Senior Program Manager directs a virtual cross-functional engineering development team. The position drives clarity by defining and prioritizing the program objectives, critical success factors and deliverables for the team. Additionally, the Program Manager
Job Description: Employer: DWS Group Title: CFO Location: Japan Job Code: #LI-ZL1 #LI-04 About DWS: Today, markets face a whole new set of pressures – but also a whole lot of opportunity too. Opportunity to innovate
Leads, guides and develops the operational activities of multiple products within an Area with moderate impact on Business Unit results. Manages the products so that the Area achieves its short- and long-term financial and operating objectives,
Location: Tokyo, Tokyo, Japan Job ID: R0052337 Date Posted: 2024-05-29 Company Name: HITACHI ENERGY JAPAN, LTD. Profession (Job Category): Legal, Compliance & Audit Job Schedule: Full time Remote: No Job Description: General information: You are expected to
Position Overview: As a post-trade sales associate, you will be part a leading multi-asset class and international clearing house, serving major international exchanges and platforms as well as a range of over-the-counter markets globally and across
JOB SUMMARY On the basis of Sanofi quality policy and Japanese regulations, make available to customers high quality products and services through promoting Quality Assurance activities strongly and leading / supporting Japanese Contract Manufacturing Organization in
Join an innovative biopharmaceutical company dedicated to pioneering advancements in healthcare. Our client is seeking a dynamic and experienced Cardiovascular Product Manager to lead our in developing and executing marketing strategies for their new cardiovascular product
Job Description The Goldman Sachs Group, Inc. is a leading global investment banking, securities and investment management firm that provides a wide range of financial services to a substantial and diversified client base that includes corporations,
