About Johnson & Johnson At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive,
Job Title Regulatory Affairs Senior Specialist Job Description Job title: Regulatory Affairs Senior Specialist Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more
Who is Weber Shandwick? Part of The Weber Shandwick Collective (TWSC), we’re the earned-first global communications agency, led by world-class strategic thinkers and creative activators. We create shared and sustainable value for businesses, people, and society.
Job Description Main Responsibilities: Will be a member of a team of Quality Assurance professionals and will manage the Quality Assurance activities of the Marketing Authorization Holder as described below: Ensures the implementation of GQP Quality
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.
Basic purpose of the job The manager of RRL JP provides strong leadership to develop and implement regulatory strategy for the assigned products/projects as RRL JP, and exercises activities which include: An integral member of the
Basic purpose of the job Insight Generation Manager is responsible for supporting therapeutic area teams with medical insight management. The role involves ensuring proper recording of scientific insights, resolving technical issues with insight capturing platforms, and
JOB DESCRIPTION: About Abbott At Abbott, were committed to helping people live their best possible life through the power of health. For more than 125 years, weve brought new products and technologies to the world -
About Boomi and What Makes Us Special Are you ready to work at a fast-growing company where you can make a difference? Boomi aims to make the world a better place by connecting everyone to everything,
企業概要 ボッシュ株式会社 法務部は、世界市場でトップクラスの自動車部品サプライヤーであるボッシュグループの本社の法務機能の一部として、日本の法令に関わる案件の支援および日系自動車メーカーとの契約交渉などの法務業務をリードする役割を担っています。 自動車及びIT業界のメジャービジネスパートナーとの国内および海外の契約交渉や、日本の法令に関する詳細な調査・分析を通じて、法務部員として個人の専門性を高めることができます。 世界各国に所在する法務チームと連携した業務遂行や、海外のビジネス部門の活動支援を行う機会があり、国際的な業務経験を蓄積できます。また、これらの活動を通じた、ボッシュグループ全体への貢献も可能です。 The Legal Department of Bosch Corporation serves as part of the headquarters legal function of Bosch Group, a leading global automotive component supplier. It plays a role in leading legal activities
Responsibilities: • Plan, direct, and monitor regulatory affairs activities so the organization has the permits, licenses, certificates, authorizations, and other approvals it needs to conduct its current and future business activities; and produce, sell, and distribute its goods
Job Description 【Main Responsibilities】 Supports new product launch projects and associated Quality & Compliance activities in accordance with established company policies/procedures and applicable governmental regulations: Supports Regulatory GMP Compliance Inspections of foreign and domestic manufacturers for
Job TitleRegulatory Affairs Manager Job Description Job title: Regulatory Affairs Manager Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation.
Translatable Rich Text As part of our global expansion, we are looking to fill a critical role in our Japanese leadership team. The General Marketing Supervisor will possess the experience, and technical skills required for assignment
Job Description: Business Overview Rakuten Group’s mission is to contribute to society by creating value through innovation and entrepreneurship. We provide over 70 various services such as an online shopping mall “Rakuten Ichiba, an online travel
Job Description 【職務概要】 ・担当疾患領域における最先端の情報を基に、Scientific Leader(SL)/Key Decision Maker(KDM)と科学的交流を行い信頼関係を構築する。 ・MSL活動で得られた情報を、社内ステークホルダーと共有する。 ・Medical Strategy(CMAP)/Field Engagement Plan(FEP)に基づくIndividual Planの作成・実行 【主な業務】 ・FM-SOP、厚生労働省の医療用医薬品の販売情報提供ガイドラインなどの社内外の規制に沿った、SL/KDMとのScientific Exchange ・SL/KDMの依頼に応じた、最新科学情報、MISP等に関わる情報提供 ・CMP/FEPに基づくIndividual Planの作成・実行 ・Scientific Exchangeを介したUnmet Medical Needs、Data Gap等のInsight収集 ・担当疾患領域に関わる論文、学会等の最新情報収集 ・SL Listの構築および更新 ・最新情報（Insight、論文情報、学会情報）の社内関連部署との共有 ・アドバイザリーボード、Medical Education等メディカルイベントのサポート 【必要な知識・スキル・コンピテンシー】 *Required ・科学的なデータを理解する基礎知識 ・担当疾患領域に対する学習意欲 ・メディカル戦略の理解と実行能力 ・複雑な情報を明確かつ端的に説明することができる
The Associated Press is an independent global news organization dedicated to factual reporting. Founded in 1846, AP today remains the most trusted source of fast, accurate, unbiased news in all formats and the essential provider of
Job Description 業務内容： グローバル戦略に沿った、効率的かつ付加価値の高い新薬等の国内開発薬事戦略の構築 規制当局（厚生労働省、独立行政法人医薬品医療機器 総合機構など）との窓口業務 承認申請・審査資料、機構相談資料、照会事項に対する回答等へのレビュー・アドバイスを通じ、当局提出文書の質の向上に資する 承認申請・審査資料、機構相談資料、照会事項に対する回答等の作成・提出のコーディネーション 新薬承認申請に関する薬事情報の収集・分析、関係者への提供／共有 当局対応（30日調査、対面助言、申請準備、審査対応）の際の、米国本社も含めた社内調整（スケジュール管理） 必須条件： ＜経歴・経験＞ 製薬系会社又は医薬品開発に関する勤務経験 承認申請・審査対応の経験 ライフサイエンス系大学院卒以上 ＜知識・スキル＞ 薬学あるいは医学に関する基本的知識 英語文献読解、国外担当者とメールでのコミュニケーションができるレベルの英語力 コミュニケーションスキル 望ましい条件、資質： ＜思考・行動＞ 前向き 論理的思考 主体・行動型 ＜知識・スキル＞ 薬機法等薬事規制に関する知識 Current Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s) Job
ジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。 Responsibilities will include, but are not limited to, the following: Develop and execute the Japan medical affairs strategy and plan for designated products and therapeutic areas in collaboration with MASL. Help identify and effectively interact with
Job Description 【Main Responsibilities】 Quality Assurance activities of the Marketing Authorization Holder as described below: Assures Quality Assurance activities operate within established policies/procedures, global requirements, and all applicable governmental regulations. Establishes and maintains robust local procedures
