Senior Specialist or Manager, Evidence Generation Force 2, ESG

Senior Specialist or Manager, Evidence Generation Force 2, ESG 正規雇用 Workday Global Grade: 15 会社概要 About AbbVie AbbVie's 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 people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. 求人内容 Mission Statement: The Senior Specialist of Evidence Generation, Evidence Solution, Medical Excellence and Operations. Medical is responsible for on-time study execution upon regulatory Post Marketing Observational Studies (reg-PMOS) and non-regulatory non-interventional studies. The Senior Specialist or Manager works as a study manager, the role involves study planning, study management and study quality management. Major Responsibilities: Work as a study manager according to the GPSP/GCP and SOP Co-development of Risk Management Plan with Pharmacovigilance Group and corresponding to PMDA Study protocol for reg-PMOS development and obtaining Abbvie Global Review committee’s approval Co-development of Study protocol for non-regulatory non-intentional studies with Medical Affairs. Study related material development Study planning (incl. feasibility, study budget, risk etc.), execution and management Management of CRO (monitoring, Data management & statistics) Essential Document archiving ミッション : Evidence Generation 、 Evidence Solution 、 Medical Excellence and Operations 、 Medical に所属するシニアスペシャリストは、規制当局向けの製造販売後調査（ reg-PMOS ）および非規制下での非介入研究を、予定どおりに実施する責任を担います。シニアスペシャリストまたはマネージャーはスタディマネージャーとして、研究計画、研究運営管理、研究品質管理を担当します。 主な職務内容 : GPSP/GCP および SOP に従い、スタディマネージャーとして業務を遂行する ファーマコビジランス部門と協働し、 PMDA 対応を含む医薬品リスク管理計画を作成する reg-PMOS の実施計画書を作成し、 AbbVie グローバルレビュー委員会の承認を取得する Medical Affairs と協働し、非規制下での非介入研究の研究計画書を共同作成する 研究関連資料を作成する 研究計画（フィージビリティ、研究予算、リスク等を含む）、運営、管理を行う CRO の管理（モニタリング、データマネジメント、統計）を行う 必須文書の保管・アーカイブを行う 資格 Essential Skills & Abilities : Candidate should have followings; Knowledge of GCP, GPSP and Ethical Guidelines for Medical and Health Research Involving Human Subjects Experience of reg-PMOS protocol development (For Manager) Business level English (TOEIC 750 or above for senior specialist, Versant 42 or above for Manager) Good communication skills Knowledge of statistical analysis is preferred Education/Experience Required : Candidate should meet one of following 5 criteria; Bachelor’s degree in a scientific field, with at least 5 years of experience as a CRA, MSL, or MR (MR only in AbbVie). Bachelor’s degree in a scientific field, with at least 5 years of experience in clinical research or observational studies. Master’s degree or PhD in a scientific field, with experience in scientific research in industry or academia. PhD in epidemiology. Healthcare-related certification preferred (e.g., MD, pharmacist, etc.). 必須スキル・能力 : GCP 、 GPSP 、および「人を対象とする生命科学・医学系研究に関する倫理指針」に関する知識 reg-PMOS