お仕事情報

お仕事情報

Medical Writing Manager:SS-3544MY

  • 外資系企業
  • 女性が活躍
  • 管理職・マネジャー
  • 英語を活かす

世界最大の独立バイオテクノロジー企業と、内資系研究開発型グローバル製薬企業との合弁会社

求人コード SS-3544MY
募集職種 Medical Writing Manager
職務内容 Job Summary
•To prepare and oversee the preparation and senior management approval of scientific and regulatory documents. To serve as functional area lead on product teams.
•Key business relationship includes Medical, Scientific Affairs, Development Operations, Regulatory, Safety, Marketing and Biostatistics.

Key Activities ​
•Independently write and translate clinical study reports, Investigator Brochures, Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, Risk Management Plans, Response to regulatory questions
•Prepare and manage the preparation of other regulatory documents and CTD sections, as appropriate (Modules 2 and 5 for CTD, Risk Management Plans, Responses to regulatory agency questions, protocols, statistical analysis plans)
•Provide functional area input for Local Regulatory Plan, Local Development Plan, and team goals
•Responsible for study timelines for regulatory documents
•Regulatory submission strategy
•Keep abreast of professional information and technology through literature, symposia, and conferences
•Participate in departmental and cross-departmental initiatives as appropriate
•Provide innovation for improving departmental processes
•Provide expertise and guidance on document design and principles of good medical writing to the department and product teams
応募要件 Basic Knowledge and Skills:
•Ability to write and speak fluent Japanese and English
•Experience in reading, understanding, and applying regulations to constantly changing environment
•Ability to effectively operate in an environment which requires negotiation, persuasion, collaboration, and analytical judgment
•Experience in understanding and interpreting data/information and its practical application
•Excellent written/oral communication skills and attention to detail
•Strong Time and project management
•Negotiating skills
•Perseverance with a drive for results

Preferred Knowledge and Skills:
•Advanced knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
•Knowledge of management skills and supervising the work of othersMentoring, training and directing others
•Developing and delegating to direct reports with a drive for results
•Understands the core business process and purpose of the functional area in Amgen's commercialization process
•Strong Leadership in a team environment. Mentoring, training and directing others
•Developing and delegating to direct reports with a drive for results

Education & Experience (Basic) ​
•Doctorate degree and 3 years of directly related experience OR
•Master’s degree and 6 years of directly related experience OR
•Bachelor’s degree and 8 years of directly related experience

Education & Experience (Preferred)
•8+ years experience in writing clinical and regulatory documents for all phases of regulatory submissions (INDs to NDAs)
勤務地 東京
年収 1000万円~1500万円
最終学歴 大卒
推奨される資格要件 PhD、理系
その他

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