Clinical Research Scientist

メルクと一緒に、あなたの力を発揮しよう！     冒険、限界への挑戦、そして発見に焦がれるあなたへ。あなたの大志を、メルクで羽ばたかせましょう！科学とテクノロジーを駆使したイノベーションに情熱を注ぐメルクのスタッフは世界中で活躍中です。ヘルスケア、生命科学、エレクトロニクスの分野で、メルクのソリューションは人々の暮らしをますます豊かなものにしています。あなたとメルクの力を合わせて、大きな夢を抱きましょう。メルクは、人、顧客、患者、そしてこの地球という惑星が共存する豊かな世界の構築に情熱を注いでいます。このためメルクでは、好奇心にあふれた人材を募集中です。メルクと一緒に、想像を超えた世界を開拓しませんか？     患者さんのためにひとつになって団結し、生命の誕生、QOLの向上、命をつなぐサポートをすることか、ヘルスケアにおける私たちの目的です。私たちは、腫瘍学、神経学、不妊治療などの疾患領域において、医薬品、インテリジェント装置、革新的技術を開発します。私たちのチームは、人生のすべてのステージで患者さんを助けるために、情熱と執拗な好奇心を持って6大陸全体で協力して働いています。ヘルスケアチームに入ることは、多様的で包含的、そして柔軟な職場文化の一部となることです。世界中で個人的な能力開発とキャリアアップの素晴らしいチャンスが待ち受けています。   Specific Job Description Key Accountabilities As a subject matter expert, the Clinical Research Scientist (CRS) partners with the Medical Lead to provide scientific, clinical, strategic, and operational input to an early or late-stage clinical development program.

The CRS contributes to data interpretation, study designs, regulatory and study documents, and publication efforts as well as providing scientific input into pipeline programs. Medical Monitoring and Medical Data Review activities are conducted in close collaboration with the  Medical Lead, including oversight of any Medical Monitoring activities performed by contracted vendors. The CRS interacts with multi-disciplinary, globa l and Japan team s ensuring that scientific, clinical and other topics are appropriately considered with respect to highly complex data findings and escalated to Medical Lead.

FINANCIAL DIMENSION Responsible for a cost-effective approach to development plan activities. Strategic Impact Within the frame of the clinical development of new medicines, the CRS is responsible for Managing assigned activities within clinical study independently and in support of the Medical Lead Providing clinical/scientific input and gathering necessary information from other areas to clinical development plans Involved in Medical Monitoring and Medical Data Review in close collaboration with the Medical Lead Assisting closely with Contract Research Organizations and other vendors on medical monitoring activities, supporting to the operational excellence of project execution in partnership with Global Development Operations Working on the design of clinical trial concepts, study protocols, assessment schedules, patient information material as well as clinical study reports in support of the Medical Lead Preparing the relevant sections of the common technical document dossier while supporting clinical trial-related submission activities and marketing authorization submissions Assisting in the design and organization of the content for relevant Advisory Board Meetings Drafting sections for clinical trial protocols, including most recent literature citations Collaborating closely with Medical Communications to ensure all relevant documentation is updated with new medical information, including assuming responsibility for the incorporation of additional information into the Investigator Brochure in coordination with various experts Cooperation Internally Externally All functions in R&D in particular Global Development Operations, Clinical Measurement Science, Global Regulatory Affairs, Medical Unit, Research Unit and Global Patient Safety, CMC Development, Global Project Management, and R&D Quality functions Commercial functions Legal, Patent, Communication functions Business Development/External Innovation and Alliance Management functions Medical experts and key opinion leaders Study-related committees External consultants for the respective projects Contract Research Organizations Site(s)/Monitor(s)   Candidate’s Profile   The CRS is an individual contributor with high analytical skills, strategic thinking, and a growth mindset.

With direct oversight and guidance, able to work on assigned tasks or projects with scientific rigor and utilizing up-to-date information technology Expert knowledge of scientific principles and concepts Knowledge of regulatory requirements, including ICH-GCP strongly p