Senior Specialist or Manager, Project Management Team, Evidence Solution Group,

Mission Statement:

The Senior Specialist / Manager of Project Management Team, Evidence Solution Group, Medical is responsible for managing the studies, such as regulatory Post Marketing Observational Studies (PMS) and Medical Research. The Senior Specialist / Manager acts as a responsible person of Evidence Solution Group and collaborate with internal and external counterparts to generate the evidence on time and on budget.

Major Responsibilities:

• For PMS, work as a project manager according to the GPSP/GCP and SOP
• Co-leading the PMS application strategy and accountable to HQ
• Managing the re-examination dossier and inspection
• For Medical Research, work as an operation manager according to the Ethical Guidelines for Medical and Health Research Involving Human Subjects
• CRO management including selection and making contract
• Leading the improvement of study process
• (Manager) Supporting colleagues and junior members with Team manager

Essential Skills & Abilities:

• Knowledge of GCP, GPSP or Ethical Guidelines for Medical and Health Research Involving Human Subjects
• Business level English (TOEIC 750 or above)
• Good communication skill
• Good negotiation skill
• Logical thinking

Education/Experience Required:

• Bachelor's degree in science who has experience as CRA or MSL
• Bachelor's degree in science who has experience as project leader or project manager
• 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.)
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