更新日 2024-05-23
掲載開始日 2024-05-23

Medical Writer at Top Global Biopharma (Kanto or Kansai)

人材紹介
スタッフレベル

この求人の取扱い会社	マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.
企業名	会社名非公開
職種	メディカル/医薬/バイオ/素材/食品 - 臨床開発系メディカル/医薬/バイオ/素材/食品 - その他
業種	製薬メーカー
勤務地	アジア日本
仕事内容	Take lead in medical writing activities in authoring clinical/regulatory documents as well as submission requirements to obtain product approval. Align with global business strategies for local requirements Description * Take lead in authoring clinical and regulatory documents as well submission requirements * Focusing on clinical parts of documentation such as CTD, CSR, IB, etc. to align company objectives in an efficient manner * Coordinate with other documentation support with external vendors such as CROs * Authoring clinical parts for briefing documents for PMDA consultation and review other requirements Profile * University degree in scientific or related field * Fluency in English and Japanese (non-native level speakers will not be selected) * Experience in clinical development with comprehensive knowledge of overall drug development process * Track record in writing clinical documents, delivery in regulatory submissions * Deep knowledge of regulations and guidelines * Experienced in supervising outsourced resources Job Offer * Competitive salaries and benefits * Great work life balance * International working environment * Amazing career progression in medical writing * Work with industry leaders who are solving various unmet medical needs Page Group Japan is acting as an Employment Agency in relation to this vacancy.
企業について（社風など）	* One of the top global biopharmaceutical companies in the industry * Specializing in oncology, infectious diseases, cardiovascular, rare disease, and other TAs for various unmet medical needs * Patient-centric organization with cutting edge products and therapies * Heavy investment in new drug development as well new research * Global cultured organization
英語能力	ビジネス会話 (TOEIC 735-860)
日本語能力	ネイティヴレベル
年収	経験と能力に基づく