Johnson & Johnson Careers

【Janssen】Group Manager, R&D Medical Writing Dept.

Chiyoda, Japan
Medical Writing

Job Description

Requisition ID: 1705615168W

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)

Primary Location
Janssen Pharmaceutical K.K. (7195)
Job Function
Medical Writing
Requisition ID