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Regulatory Writing Manager

年収:1000万 ~ 1300万

ヘッドハンター案件

部署・役職名 Regulatory Writing Manager
職種
業種
勤務地
仕事内容 <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 our company, 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
応募資格

【必須(MUST)】

<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


【歓迎(WANT)】

<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 our commercialization process
・Leadership in a team environment

更新日 2019/05/13
求人番号 984543

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