お仕事情報

お仕事情報

Regulatory Writing Sr Associate:SS-4157MY

  • 外資系企業
  • 女性が活躍
  • 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-4157MY
募集職種 Regulatory Writing Sr Associate
職務内容 Job Summary:
・To prepare and gain approval of scientific and regulatory documents
・To maintain key business relationships with appropriate members of Marketing, Safety,
Regulatory, Global Health Economics, Team Leaders, Biostatistics and Clinical Development at us, and Global Regulatory Writing.
・As requested, this role may serve as functional area lead on product teams, train and mentor Japan medical writers, and assist with departmental activities.

Key Activities:
・Independently write Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical
Overview, Table of All Studies, Briefing Documents, Responses to Regulatory Agency
Questions
・Oversee and manage the formal review and approval of scientific and regulatory documents
・Participate in the development of timelines for regulatory documents and lead preparation of assigned deliverables
・Contribute to Japan regulatory submission strategy for teams in assigned product areas
・May serve as functional area representation on Japan product teams
・May provide functional area input for Japan Regulatory Plan and team goals
・May work with contract and CRO writers
・May participate in training and mentoring of junior medical writers
・May participate in departmental and cross-departmental initiatives, as appropriate
・Keep abreast of professional information and technology through literature, symposia, and conferences
応募要件 Basic Knowledge and Skills:
・Experience 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 understanding and interpreting scientific data/information and its practical
application
・Written/oral communication skills and attention to detail.
・Time and project management skills
・Negotiating skills
・Perseverance with a drive for results

Preferred Knowledge and Skills:
・Knowledge of scientific/technical writing and editing
・Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
・Understanding and application of principles, concepts, theories and standards of
scientific/technical field
・Understands the core business process and purpose of the functional area in Amgen's
commercialization process
・Leadership in a team environment
勤務地 東京
年収 600万円~900万円
最終学歴 理系大卒
推奨される資格要件 理系
その他

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