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.
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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
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.).
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。