Job Description
RADDS Japan was established to support EBP initiative for business growth in RD&S. This position requires the successful candidate to support the activities in RADDS Japan which includes contributing to the scoping, integrated proposal compilation, and delivery oversight of multi-disciplinary biopharmaceutical development advisory/clinical trial enablement projects.

【業務内容】
・Manage staff in accordance with organization’s policies and applicable regulations; Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; Approve actions on human resources matters, including salary administration.

・Effectively manages the team's resources and delegates tasks commensurate with skill level; Evaluates workload, quality and metrics through regular review and reporting of findings;
Effectively collaborate with operational colleagues to manage project- and team-related challenges;
Contributes to discussions on implementation of business strategy on a regional basis and will implement regional and global specific objectives, as appropriate.

・Ensures staff have a consistent understanding and positive impression of strategy for regional and global objectives; Leads strategic initiatives and develops implementation plans;

・Will have full financial responsibility and accountability for one or more Regulatory Affairs sites; monitors growth and performance of the sites;
Undertakes risk analysis and manages the outcome as appropriate;

・May act as a Project Manager for a large and complex stand-alone project or programme, involving several regulatory or technical deliverables and/or region, and/or operations;

・May provide strategic regulatory and/or technical consultancy on a variety of projects;

•Competently manages meetings/expectations with Regulatory Agencies and/or groups within IQVIA;

•May take leadership role in bid defense strategy and planning;

•May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience;