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 PMDA

• Study protocol development and obtaining Abbvie Global Review committee’s approval

• Study 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 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 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 years

• Bachelor's degree in science who has experience as clinical research at least 5 years

• Master or PhD in science who has experience with scientific research in industry or academia

• PhD 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。

Abb Vie'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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.