Work Schedule Other Environmental Conditions Office Job Description 職務内容: 医療機器、体外診断用医薬品、動物用医薬品、研究用試薬（消耗品、機器含む）に係る薬事対応業務 ・製造販売業の維持・管理（更新申請手続き等、3役会議事務局運営など） ・販売店が保有する高度医療機器販売業・貸与業、医薬品販売業、動物用医薬品卸売販売業の管理 ・QMS適合性調査申請（承認前調査/定期調査） ・外国製造業者認定・登録の維持・管理 ・QMS内部監査対応（被監査部門への監査の実施、報告書作成保管等 1回/年） ・GVP対応（情報収集、当局報告、記録書作成保管等） ・薬事トレーニングの実施管理（年間計画の立案、トレーニング資料作成、e-learning等での実施、記録書作成保管等） ・プロモーションマテリアルレビューの管理 ・海外拠点及び顧客からの問合せ対応 必要とされる資格・経験 ・医薬品、医療機器、又は体外診断用医薬品分野におけるRAQAでの業務経験（1年以上） ・薬事規制（特に安全管理業務）に関する知識 ・当局対応経験 ・海外とコミュニケーションを行う英語力（メール対応） ・基本的なPCスキル（Word、Excel（表計算・グラフ作成）、PowerPoint） 歓迎される資格・経験 ・規制当局又は認証登録機関によるQMS適合性調査・ISO13485調査対応経験 ・安全性に関わる業務経験 ・ドキュメント管理システムの使用経験 ・製造販売業の三役の経験 Thermo Fisher Scientific Inc. is
Key objective of the role: Provide an exceptional level of organizational, secretarial, billing and admin support to the lawyers within the department. Also to be recognised throughout the firm as reliable, responsible and trusted employees who
Position summary The occupational health physician will be expected to provide OH related care to the site J&J employees. Additionally, the physician would need to provide expertise in the prevention, evaluation, and management of conditions that
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Title: Regulatory Affairs Manager Company: IPSEN K.K. Job Description: Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’
About Four Seasons: Four Seasons is powered by our people. We are a collective of individuals who crave to become better, to push ourselves to new heights and to treat each other as we wish to
City/State Elizabeth City, NC Overview Work Shift First (Days) (United States of America) As a Patient Care Specialist with Sentara Healthcare, you will provide non-clinical support within a physicians office and ensure an excellent patient experience
N/A RESPONSIBILITIES Head of Operation Be compliant with applicable laws to handle pharmaceutical products Supervise the activities related to receiving / shipping / storage and inventory. Responsible for warehouse management . Responsible for safety management Responsible
JOB SUMMARY On the basis of Sanofi quality policy and Japanese regulations, make available to customers high quality products and services through promoting Quality Assurance activities strongly and leading / supporting Japanese Contract Manufacturing Organization in
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health
SUMMARY Responsible and accountable for Medical Affairs strategy of Urological cancer products C ollaborates with internal and external stakeholders including key opinion leaders to develop and implement the overall M edical Affairs strategy for product lifecycle
Blackstone is the world’s largest alternative asset manager. We seek to create positive economic impact and long-term value for our investors, the companies we invest in, and the communities in which we work. We do this
職種 正社員 職務明細 MD (Merchandiser) About the job: This role is for one of the Fashion brands in the LVMH Group in Japan. We are looking for someone who has the potential to grow and develop
職種 正社員 職務明細 Job Scope - Consultant for improving dealer service business & process, service structure & service profit based on Stellantis Japan (SJ) service strategy - Enhancement of AM’s activities. (Strategy, Target setting, Progress, Result,
職種 パートタイム 職務明細 Tokyo American Club is the most well-known and highly reputed private club in Japan. We have a 90 year history and have received international recognition such as Distinguished Clubs and Platinum Clubs of
職種 正社員 職務明細 Tokyo-based Langley Esquire is a public affairs consulting firm specializing in government relations, strategic communications, and public policy. We overcome challenges at the nexus of government, industry, and society. With over 30 years
職種 正社員 職務明細 Workato (ワーカート) is a world-recognized software leader in enterprise automation. Founded in 2013, it is a startup company from Silicon Valley in the United States. We launched our Japan operation in 2018. We
Company Description The history of Bosch is the history of car evolution. As a top-class automotive equipment supplier, Bosch Corporation supports market expansion/inroads domestically as well as globally. Bosch will continue to pursue forward-looking technologies such
Job Responsibilities Manages legal business matters pertaining to the organization. Provides a variety of general corporate and commercial legal services to a number of in-house clients. Acts as advisor on legal issues involving the organization’s government
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
