Specialist, Medical Writing

About the role

Purpose ・Prepare high-quality and accurate NDA-related documents (CSR, CTD, etc.) in accordance with regulatory requirements based on policies of global R&D and Japan Development. ・Cooperate with the lead-writer for the formulation of strategies such as policy, schedule, budget, etc. for preparation of NDA-related documents as a sub-writer of the project in charge. Major Responsibilities: Prepare NDA-related documents and arrange their quality control as a sub-writer. Make every effort to prepare high-quality NDA-related documents in accordance with pharmaceutical regulations, SOPs, manuals, etc. Participate in the decision making of the assigned JDT with the lead-writer. Cooperate with lead-writer in the formulation of strategies such as policy, schedule, budget, etc. for preparation of NDA-related documents of the project in charge. Prepare appropriate procedures for development and maintenance of NDA-related documents. Build cooperative relationships with stakeholders in Global MW. Prepare/update appropriate procedures for the vendor management. Conduct liaison activities with the vendor regarding preparation of NDA-related documents. Bachelor's degree in pharmacy, biology, chemistry, pharmacology or other related academic area or equivalent ability is required. Master's or doctor's degree is preferred. TOEIC 600 or more or equivalent English communication skill are required. At least 3 years' experience in or equivalent skill for medical writing, clinical development, regulatory affairs, post-marketing surveillance. Experience of attending the medical writing training course hosted by an organization (e.g., Union of Japanese Scientists and Engineers, Japan Medical and Scientific Communicators Association) related to medical writing is preferred. アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。

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