会社概要

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

求人内容

For Grade 16 Senior Specialist
• Prepare NDA-related documents and arrange their quality control as a lead-writer.
• Make every effort to prepare high-quality NDA-related documents in accordance with pharmaceutical regulations, SOPs, manuals, etc.
• Contribute to the decision making of the assigned JPT on behalf of Medical Writing Group.
• Contribute to the assigned JPT by the support of developing regulatory documents, such as answers to regulatory queries and briefing books.
• Formulate strategies such as policy, schedule, budget, etc. for preparation of NDA-related documents of the project in charge and propose them to JPT.
• 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.
• Support to develop other medical writers who they cooperate with, with the support of the supervisors if necessary.

For Grade 17 Senior Specialist (In addition to above )
• Cooperate with the Group Manager/TA Manager for the management and operation of Medical Writing Group, from the specialist’s perspective.
• Give advises on the document structure and contents of NDA-related documents of the assigned JPT, based on the medical writing industry tendencies and abundant experiences.
• Prepare appropriate procedures for development and maintenance of NDA-related documents, within medical writing group and/or in cooperation with the related departments.
• Contribute to develop other medical writers and JD members who they cooperate with by offering training etc.

資格

• 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 700 or more or equivalent English communication skill are required.
• At least 5 years’ experience in or equivalent skill for clinical development, regulatory affairs, post-marketing surveillance including any medical writing experience.
• 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.

その他の情報

AbbVieは、誠実な事業運営、イノベーション推進、人々の生活の変革、地域社会への貢献、そしてダイバーシティ＆インクルージョンの促進などに尽力しています。AbbVieの採用方針は、人種や肌の色、宗教、国籍、年齢、性別（妊娠を含む）、身体的・精神的障がい、病気、遺伝情報、性同一性または表現、性的指向、婚姻状況、退役軍人やその他法的に保護されたグループに属するかどうか等に関わらず、高い能力を持つ優秀人財を従業員や候補者として差別することなく雇用することです。