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新着求人情報
新着求人 MD  (MD-40)
募集職種 外資系製薬企業の 医薬開発本部クリニカルプログラムリード(免疫・CNS)
その他のメディカルドクターの求人はこちら
勤務地 東京
会社概要 非公開
求人要件 •Strengthen products’ profile by providing robust medical/scientific guidance through the total process of the clinical development in collaboration with * corporate, other departments in Medical Division, and Marketing.
【Tasks & responsibilities】
•As Local Clinical Program Leader you assume responsibility for preparing the Japanese clinical development plan for projects in the indication area Immunology from start of development to registration
•You work in close collaboration with other local and global Medicine functions to prepare a local input that reflects the Japanese patients’ needs, maximize the value of local academic knowhow and is aligned with the global development strategy and recognized by *’s global medicine
•You are accountable for the strategic planning, oversight and execution of the program in Japan. Ensuring that all projects are correctly managed in both timelines and quality
•With your expertise and scientific insight, you lead the regulatory strategy, ensuring successful submission and approval as clinical development lead
•You ensure that development product has a positive benefit risk, justifying development in Japan
•You present and defend the project to internal decision committees as well as to external stakeholders, e.g. regulatory authorities and external experts
•In your new role you are expected to establish strong network with Japanese external experts. In addition, to transfer knowledge internally to other relevant business functions
必要要件 【Requirements】
Medical degree or PhD in life sciences with clinical and/or research experience in dermatology, rheumatology, immunology or relevant specialty
•At least 3 years’ experience in pharmaceutical industry in clinical development or medical affairs role
•Preferably prior experience with submission of documents to regulatory agencies in Japan
•Good project management and excellent cross functional collaboration skills with ability to work with global matrix teams
•Agile and effective working style in a fast-paced and changing environment
•Fluent in Japanese and English with very good communication and presentation competencies
•Willing to work in a global environment
年収 能力、経験を考慮の上、当社規程により優遇 
募集背景 非公開 
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