RA Strategic Medical Writer

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About the role

Purpose Statement: • Prepare high-quality and accurate Japan-specific regulatory and clinical documents in accordance with regulatory requirements based on policies of Global R&D including Global SMW, and Japan Development. • Provide project management for all projects for assigned team. • Serve as local coordinator to streamline the communication between Japan project team and all global stakeholders including global medical writing team (Strategic Medical Writing [SMW]). • Liaison activities with medical writing vendor in Japan as needed regarding preparation of regulatory and clinical documents. Major Responsibilities: • Provide effective leadership of assigned work to support smooth progress of each project in accordance with pharmaceutical regulations, SOPs, manuals, etc.   Primary remit includes but is not limited to: • Briefing books including those for PMDA consultation/pre-meeting • Request form for PMDA consultation/premeeting • Responses to PMDA/MHLW for (s)NDA, PMDA consultation, and CTN, including being part of the Rapid Response Team (RRT)/Labeling Subteam (LST) Responses to Agency Questions including ad hoc requests including those for PMDA consultation/premeeting documentation • J-CTD Module 1 to include Japan package insert • Japan s(NDA) application form • Orphan Drug Designation request form, briefing book, application form • Sakigake Designation request form, briefing book, application form • Specific Use designation request form, briefing book, application form • Japan Package Insert Maintenance, including update of side effect sections, assessment description based on CCDS revision • Japan CTD updates during (s)NDA • Post-submission safety updates • Advise on the document structure and content based on medical writing industry best practices and experience in medical writing. • Formulate assignment plan and timeline for responsible cross-functional team members to each project, collecting the inputs from Japan project team and managing the project to completion. • Build cooperative relationships with all cross-functional stakeholders both local and global (Global R&D, Development TA, Data & Statistical Sciences, Global Regulatory Strategy, Global SMW, Clinical Sciences, Japan Project Team, TAG, JDSSG, vendors) • etc.) and effectively represent SMW at assigned meetings, as necessary. • Prepare/update appropriate procedures when using a medical writing vendor. • Ensure that appropriate quality control (QC) checks are performed on medical writing deliverables, as required. Ensure authoring and review with the electronic document management system. • Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or other related academic area or equivalent ability is required. Master’s or PhD/MD degree is preferred. • At least 5 years’ experience in or equivalent skill for clinical development, regulatory affairs, post-marketing surveillance including at least 2 years’ experience in medical writing. • Ability to communicate clinical data succinctly, clearly, and accurately in writing. • A good team player and good planner with proactive, accountable, and details-oriented mindset • Must have excellent fluency in both oral and written communication skills in both Japanese and English. • Excellent skill for operating Microsoft Office (Word, Excel) and Adobe Acrobat 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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