Senior Specialist or Manager, Evidence Generation Force 2, Evidence Solution, Medical Excellence & Operations

Company Description

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.

Job Description

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

Qualifications

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.).

Additional Information

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。