薬事申請担当者として、医療機器等の規制要件を遵守し、製品の承認・認証取得および維持に必要な薬事申請業務を担当する。また、新製品の申請業務に加え、既存製品の変更管理や承認維持に関連する薬事対応を通じて、製品が日本市場でタイムリーかつ継続的に使用可能となるよう貢献する重要な役割を担う。 主な業務内容 １．薬事申請書類の作成、提出、照会対応、承認等の取得 PMDAおよび認証機関等との対面助言を含む相談の業務 既存製品の変更管理に関する薬事対応 米国製造元及び社外及び社内関連部署との連携及び協力体制の構築 保険収載業務（保険適用希望書作成等）...
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
企業概要 We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North
Job Overview: Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports).
Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the
Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity.
About Welo Life Sciences Welo Life Sciences, a Welo Global brand, is a specialized language and technology partner serving pharmaceutical, CRO, and medical device organizations operating in regulated global markets. We deliver regulator-ready translation, linguistic validation, and localization
About Welo Life Sciences Welo Life Sciences, a Welo Global brand, is a specialized language and technology partner serving pharmaceutical, CRO, and medical device organizations operating in regulated global markets. We deliver regulator-ready translation, linguistic validation, and localization