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。
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.