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Manager, Communication Compliance

Japan • Posted: 2022-07-27 • 22 Views

Job Overview & Requirements

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. 職務内容サマリコミュニケーション・コンプライアンス部のmissionは、科学的かつ適正な情報提供を通じ、重篤な疾患を持つ患者及び医療従事者の最適な判断に貢献し、患者のよりよい生活の実現に貢献することである。またvisionは、1.秩序とリーダーシップに基づき、患者及び医療従事者に適切で解りやすい情報をタイムリーに提供すること、2.変化し続ける医療従事者と患者のニーズに応じたノウハウを継続的に蓄積することによりOperational Excellenceを追及すること、である。 製薬企業から社外に向けて発される当社製品関連情報に求められる正確性・妥当性の基準は厳格化の一途をたどっている。一方で情報伝達形態は多様化・複雑化している。こうした背景のもと、このポジションは、プロモーション及びその周辺の対外的資材・コンテンツ等のレビューと承認を行う。 The mission of Medical Capabilities is to contribute to realizing better patients’ life by serving for optimal judgment by the patients with serious disease and HCP through scientific and appropriate information provision. The vision is 1. to deliver appropriate and comprehensive information in a timely manner under order and leadership, 2. to pursue operational excellence by continuously accumulating knowledge in accordance with the changing needs among HCP and patients. The expected functions are the following four areas: MCCI (Medical Contacts, Contents and Insights), Medical Publications, Medical Operations and Intelligence Center. The criteria of the accuracy and adequacy required for product-related information from pharmaceutical companies to external audiences is getting stricter and stricter while the communication channel is becoming diverse and complex. Under these circumstances, this position is responsible for the internal review of promotional and related materials and contents for direct / indirect external use. 職務内容 1)各種コミュニケーション資材レビュー The review of various communication materials 医学・科学的妥当性、関連各種規制・コードへの準拠、製造販売承認事項との整合性の観点から下記のレビューを行う。 Conduct material review for the following cases based on (a) medical and scientific accuracy, (b) compliance with relevant regulations and codes, and (c) consistency with the contents/conditions of regulatory approval 1.日本製薬工業協会(製薬協)の定める「医療用医薬品製品情報概要等に関する作成要領」に該当する資材をレビューする。 Review the materials within the scope of JPMA Guideline for the Preparation of Product Information Brochure of Ethical Drugs and the Preparation of Advertisements of Ethical Drugs Inserted in Scientific Journals (Papers) 2.上記1以外の対外的コミュニケーションのうち、社内手順でレビューを要すると定められた資材をレビューする。 Review the external communication materials outside 1 (above) that internal procedure requires review. 3.社内コミュニケーションのうち、社内手順書でレビューを要すると定められた資材をレビューする。 Review the internal communication materials that internal procedure requires review. 4.固形がん領域の製品のプロモーション資材審査などを中心にレビュー業務を行う Review work with a focus on promotional materials review for products in the Solid cancer. 2)知識の更新・能力の向上 Update knowledge and further develop capabilities 担当疾患領域・製品に関する学術知識の向上・更新に努める。 Strain to enhance and update the medical / scientific knowledge of the responsible therapeutic area and products. 製薬協をはじめとする各種社外規制・ルールに関する知識の向上・更新に努める。 Strain to enhance and update the knowledge of various external regulations and rules such as JPMA. 3)チーム貢献 Team Contribution 1.チームの目標に沿って業務を推進するとともに、チームメンバーをサポートし、協力・協業する。 Complete tasks along with the team objectives. Support, collaborate with team members. 4)社内トレーニングの企画・実施・トラッキングを行う。 Plan, implement and track internal stakeholder training. 1. 社内オリジネーター、社外資材作成者のトレーニングを企画・実施する。 plan and conduct training for internal originators and external material preparers 2. トレーニング用資料を作成・更新する。 create and update training materials 5)各種コミュニケーション資材の社内レビュー体制の構築・維持を行う。 Be in charge of BMSKK promotion material as a person responsible for implementation, and/or VeeVa system for JPMA, if appointed. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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Job Summary

Category Vacant
Country Japan
Employment Type Full Time
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