About this role
企業概要
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
求人内容
Purpose Statement:
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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.
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Provide project management for all projects for assigned team.
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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]).
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Liaison activities with medical writing vendor in Japan as needed regarding preparation of regulatory and clinical documents. Major Responsibilities:
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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:
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Briefing books including those for PMDA consultation/pre-meeting
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Request form for PMDA consultation/premeeting
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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
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J-CTD Module 1 to include Japan package insert
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Japan s(NDA) application form
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Orphan Drug Designation request form, briefing book, application form
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Sakigake Designation request form, briefing book, application form
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Specific Use designation request form, briefing book, application form
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Japan Package Insert Maintenance, including update of side effect sections, assessment description based on CCDS revision
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Japan CTD updates during (s)NDA
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Post-submission safety updates
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Advise on the document structure and content based on medical writing industry best practices and experience in medical writing.
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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.
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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)
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etc.) and effectively represent SMW at assigned meetings, as necessary.
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Prepare/update appropriate procedures when using a medical writing vendor.
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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.
資格
- 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.
その他の情報
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。