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ASAstrazeneca logo

Astrazeneca

Japan - Tokyo, Japan

【Alexion Japan】Associate Director Promotion Audit.

LEADERSHIPFINANCE & LEGAL
This is what you will do: プロモーション監査室はアレクシオンファーマGKの企業活動において各種法令、政令、業界自主規制等を遵守する体制を構築、維持、管理する。 「医療用医薬品の販売情報提供活動に関するガイドライン」(以下、販売情報提供GL)に規定される販売情報提供活動監督部門としての役割を担う。 医療用医薬品製造販売業公正取引協議会の窓口部門を担う。 本ポジションは、プロモーション資材および関連イベント申請が法規・各種コード・社内規程に適合しているかを確認し、最終承認(サインオフ)を行う役割を担う。 監督部門として、販売情報提供ガイドラインに基づく体制(運用基準・承認フロー・記録管理など)の整備と継続的なモニタリングをリードし、必要に応じて是正対応や教育を実施する。 業界団体(公正取引協議会)や社内外のステークホルダーとの連携・窓口を担い、最新の規制・ガイダンスの社内展開を推進する。 You will be responsible for: 販売情報提供活動のモニタリング業務(監督部門としての体制整備・運用状況のレビュー、記録管理、是正措置のフォローを含む) 各種資材の審査・最終承認業務 各種イベント申請の審査・最終承認業務 社内コンプライアンス関連ルール(SOP等)の作成・管理(承認プロセスの設計・標準化、販売情報提供ガイドラインに基づく運用基準の整備を含む) コンプライアンス関連研修の企画・実施 関連部署からの各種コンプライアンス関連相談への対応 必要に応じてコンプライアンス部門、法務部門、経営陣との協議・協働・調整 業界団体(公正取引協議会)との連携・窓口対応、および外部ガイダンスの社内展開・周知 You will need to have: 製薬企業における勤務経験10年以上 製薬企業における資材審査、イベント審査の実務経験、またはコンプライアンス関連部署における実務経験 薬機法(医薬品広告規制)、販売情報提供GL、公正競争規約、作成要領など製薬業界におけるコンプライアンス関連知識、製薬企業の対外的活動に関する包括的な知識を有する PC: Excel、Word、Power Point、Outlookをビジネスに利活用可能なレベル 言語:日本語:日常会話レベル、英語:ビジネス文書作成・読解レベル We would prefer for you to have: 製薬企業においてマーケティング部門またはメディカル部門で承認資材を作成した経験3年以上 講演会、学会共催イベント、アドバイザリーボード会議等のイベントを主幹担当した経験3年以上 部署内、他部署と良好なコミュニケーションができる 研修、会議等において分かりやすいプレゼンテーションができる アレクシオンファーマGKが事業展開する疾患領域の知識を有する 根拠に基づいた客観的で公正な判断ができ、論理的で説得力のある説明ができる 公正取引協議会等の業界団体との連携・折衝の経験、または外部ガイダンスの社内展開・教育のリード経験があるとなお望ましい Date Posted 22-10月-2026 Closing Date 30-1月-2027 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.
Pay
Not stated
Where
Japan - Tokyo, Japan
Work
Not stated
Type
Not stated
Posted
22 Oct, 2026
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