Johnson & Johnson キャリア
【JAN】 Group Manager, R&D Medical Writing Department
Requisition ID: 1805663030W
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.
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)
M.S. or equivalent is required.
[Other Requirement/ Motivation and Leadership]
Motivated to people development
With strong leadership capable of management of the organization
Motivated to the process improvement
Janssen Pharmaceutical K.K. (7195)