神奈川 化合物管理業務 高度技術者

臨床試験データの統計解析。 ＜主な内容＞ ・統計解析ソフトSASによるプログラミング、仕様書の作成。 ・SDTM・ADaMデータセットの作成。 ・総括報告書(CSR)用の解析結果の作成。

医薬品開発に関る臨床試験、製造販売後臨床試験におけるモニタリング業務。

医薬品・再生医療等製品に関わる臨床試験のモニタリング業務。 モニタリング業務（全て又は一部）を行っていただきます。 契約事項、GCP、SOP、その他関連する法規制等を遵守し、受託したプロジェクトにおけるモニタリング業務全般の実施、また治験実施計画書等に従って治験が実施されていることをモニタリングする責務を担っていただきます。分業制ではなく、試験の立ち上げから終了までの一連の業務に携わることができます。 ※所属は、モニタリングセンターかグローバルリサーチセンターのいずれかを予定しております。

職務内容 製薬企業が作成する以下のメディカル関連資料や文書の作成支援業務 ・医学論文案（主に臨床関連、治験、臨床研究、製造販売後調査、等） ・学会発表資料案（抄録、ポスター、スライド、等） ・学術資材（製品情報概要、インタビューフォーム、適正使用ガイド、患者向医薬品ガイド、等） ・添付文書（電子添文） ・製造販売後調査に関連する文書（プロトコル、ICF、CSR、等） ◆上記のいずれかに対応できる方であれば応募可能です 当ポジションの特長 ・安全性定期報告や再審査申請資料等、GPSP/GVP関連文書の作成を主な業務としていますが、それ以外にも製薬企業やアカデミア等の依頼に応じて様々な文書や資材のライティング業務を実施しています。そのため、様々なバックグラウンドの方が在籍しており、未経験の方でもチャレンジすることができます。 ・落ち着いた環境で業務に専念することが可能です。今まで以上に専門性を高めることや、スキルアップが期待できます。 ・これまでに作成経験の無い文書にも、各人の意欲に応じて挑戦することが可能です。いずれはライティング業務のエキスパートを目指せます。 ・ライティング業務の多くはリモートワークでの対応が可能です。所属長の了承のもと、業務状況により、出社か在宅か、各自で予定を立て就業することが可能です。

Accountabilities： Leads and manages a group of Engineers, providing technical guidance, mentoring, and performance management to ensure the team's success and professional growth. Develops project and/ or significant technical strategy and leverages technical skill(s) as a resource/expert within the department. Collaborates closely with cross-functional teams, including process chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs, to develop and implement effective process engineering strategies. Drives process optimization initiatives to improve sustainability, process efficiency, yield, quality, and cost-effectiveness, utilizing expertise in process chemistry and fundamental engineering principles. Oversees process scale-up activities from laboratory to pilot plant and commercial-scale production, ensuring smooth technology transfer and process validation. Has full accountability for all engineering aspects for multiple pipeline projects. Initiates complex projects with extraordinary technical challenges and applies strong technical risk assessment skills. Owns a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills. Contributes significantly to develop, drive and set the vision and direction of departmental activities, management of resources, time, personnel and financial resources. Maintains ownership of overall vision of scientific platform. Communicates and coordinates implementation of technology/scientific improvement to senior management, across therapeutic and scientific areas. Conducts analysis of technical and conceptual risk through robust process characterization, failure mode analysis, and risk assessment methodologies, identifies trends and defines and champions process or scientific strategies. Incorporates novel manufacturing, technologies and industry trends as a key aspect of scientific strategy development. Maintains complete technical responsibility for program(s)/initiative(s) within the department. Leverages cross functional knowledge to guide pharmaceutical sciences teams on potential impact of actions across projects, particularly in technical aspects. Ensures effective project management of all plans and projects within area of responsibility, linking all scientific efforts to company, program and functional goals. Leads small working groups as appropriate to address knowledge gaps in programs linking departmental strategy to strategies of other relevant functions. Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff. Recognized as a technical leader/resource by the group and fosters development of technology skill sets within department and among junior staff. Contributes to departmental strategy around scientific improvement and new capabilities. Makes proposals regarding sourcing/consultancy strategy. Coordinates and leads technology transfer to internal or external manufacturing sites or vendor Communicates with senior management of other functions on implementation of infrastructure, technology, work processes, or business processes. Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), process descriptions and peer reviewed manuscripts. Defines outsourcing strategy for department in conjunction with senior staff. Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver against pipeline goals. Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors. Represents is an active member on pre-competitive collaborations with academic and industrial partners.

Accountabilities: Develops project or significant technical strategy and leverages technical skill(s) as a resource/expert within the department Contributes significantly and independently to project work which may include multiple projects within functional area. Plans and implements resolutions to technical problems/issues Independently designs and executes experiments, and reports results Recommends, justifies and implements technologies and innovations. Owns a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills. Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally. Reviews, interprets and communicates data cross functionally within pharmaceutical sciences and project teams Conducts analysis of technical and conceptual risk and trends Identifies process trends and defines/champions process strategy or use of novel technologies Recognized as a technical expert and resource within function Significant technical responsibility for a project area/technical program within the department and potentially across Pharmaceutical sciences Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff. Defines appropriately complex/novel approaches and methodologies to solving outstanding technical challenges Coordinates and leads technology transfer to internal or external manufacturing sites Responsible for authoring relevant sections of regulatory documents, validation plans, reports and peer reviewed manuscripts. Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals. Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors. Represents is an active member on pre-competitive collaborations with academic and industrial partners. Education and Experience: A Ph.D. degree with 3+ years of academic, post-doctoral or pharmaceutical industry experience; an MS degree with 9+ years of pharmaceutical industry experience; or a BS degree with 11+ years of pharmaceutical industry experience. Degrees in chemical engineering required. Experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems preferred Experience in building reaction kinetic models as well as process models preferred. Experience in building laboratory and pilot plant equipment a plus Experience in crystallization process development and scale-up with an emphasis on form, purity, and particle size control a plus Experience in the use and scale-up of milling technologies (both dry and wet) for particle size control a plus Experience in the use of process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.) required Experience in building chemometric models preferred Experience in developing continuous processes a plus Sound knowledge of current Good Manufacturing Practices (cGMP) preferred Experience working in a pilot plant a plus Previous experience with the use of contract facilities and managing technical transfers a plus Experience in working in a multi-disciplinary team environment Proven scientific track record through presentations at scientific conferences and publication of pier reviewed manuscripts