Responsible for managing the activities of the group in preparing sound scientific/clinical documents in assigned areas using established templates and guidelines. Is highly independent.
Responsible for the efficiency of the department as well as the quality, considering the business impact.
■Oversee and manage the activities of the group.;
■Prepares and finalizes clinical and regulatory documents (CSR, CTD for Clinical Parts and HA response document, IB, briefing documents, Manuscript) with quality.
■Assist the group member to plan and evaluate performance.
■Mentor, coach, train and develop the direct reports. Evaluate performance and provide opportunities for growth.
■Manage Resources, implement recruitment and develop sourcing strategy to ensure the MW deliverables.
■Develops budget and monitor the controlling of expenditures.
■Drives the implementation of process improvements.
■Lead cross-functional task force team as required.
Professional Experiences ：
-Medical Writing, Regulatory, or Clinical Development experiences in the pharmaceutical industry of >12 years with experiences in approvals.
-Experiences of People Management
Skills & Competencies ：
-Fluent business English skill (TOEIC 700 or above)
-Excellent communication skill with internal/external stakeholders
-Negotiation and coordination skills with CROs on outsourcing of the documentation
-Basic PC skills (Word，Excel，Power Point)
Janssen Pharmaceutical K.K. (7195)ジョブ
Medical WritingRequisition ID