About this role
Mission Statement:
The Senior Specialist or Manager of Study Execution Team, Evidence Solution Group. 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 contains 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 PMDAStudy protocol development and obtaining Abbvie Global Review committee’s approvalStudy Protocol translation and study related material development Study planning (incl. feasibility, study budget, risk etc.), execution and management Education of the study for Study Monitoring organization (MR/CRO) Essential Document archiving Essential Skills & Abilities: Candidate should have followings;
Knowledge of GCP, GPSP and Ethical Guidelines for Medical and Health Research Involving Human SubjectsExperience 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 skill
Education/Experience Required: Candidate should meet one of following 4 criteria;
Bachelor's degree in science who has experience as CRA or MSL (or MR; only in Abbvie) at least 5 yearsBachelor's degree in science who has experience as clinical research at least 5 yearsMaster or PhD in science who has experience with scientific research in industry or academiaPhD in epidemiology Healthcare related certified person preferred (eg, MD, pharmacist, etc.) アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。