Johnson & Johnson キャリア

【JAN】 Group Manager, R&D Medical Writing Department

千代田区, 日本
Medical Writing


仕事内容

Requisition ID: 1805663030W

[Job Description]

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.



資格

[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)

 
[Certifications]

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

 


プライマリ場所
日本-東京都-千代田区
組織
Janssen Pharmaceutical K.K. (7195)
ジョブ
Medical Writing
Requisition ID
1805663030W