職種 フルタイム(契約) 職務明細 EssilorLuxottica is a leader in the design, manufacture and distribution of fashion, luxury and sports eyewear. Its portfolio includes proprietary brands such as Ray-Ban, Oakley, Oliver Peoples and Alain Mikli, as well as
Work Schedule Other Environmental Conditions Office Job Description When you’re part of the team, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe.
Job Description: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we
If you have what it takes to become part of the Vistra family and would like to start a promising career with a global leader, take a look at the exciting employment opportunities that are currently
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
Job Description The Goldman Sachs Group, Inc. is a leading global investment banking, securities and investment management firm that provides a wide range of financial services to a substantial and diversified client base that includes corporations,
About Dexcom Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The
Company Description Who is Turner & Townsend? All over the world people are using buildings, infrastructure, and assets we helped to deliver. It could be the hospital they work in, the railway they travel on every
Career Category Clinical Job Description Responsible for Ensuring that all statistical aspects of documentation pertaining to clinical programs and non-study activities meet required standards and are statistically correct. Influencing study design and analysis, and defending statistical
Görev Tanımı The Position Individual contributor is accountable for ensuring all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution
Job Description The position takes a responsibility for medical contents in all clinical development programs in assigned therapeutic areas (such as dementia, movement disorders, neuromuscular, and MS/Immunology etc.) in Japan. The individual functions as a scientific
If you have what it takes to become part of the Vistra family and would like to start a promising career with a global leader, take a look at the exciting employment opportunities that are currently
PURPOSE AND SCOPE: Functions as part of the dialysis health care team in providing safe and effective dialysis therapy for patients under the direct supervision of a licensed nurse in accordance with organization policies, procedures, and
■ 職務内容 / Job Description Drive development and execution of external communications strategy to drive a corporate reputation and advance science and therapeutic area leadership of AZKK. Leads a team of external communication managers and specialists
Medical Advisors provide medical and scientific expertise and guidance to investigators and CSU (Clinical Study Unit) staff performing clinical trials within a CSU cluster to ensure patient safety and scientific integrity of the protocol which ensures
Company Description Who is Turner & Townsend? All over the world people are using buildings, infrastructure, and assets we helped to deliver. It could be the hospital they work in, the railway they travel on every
Are you ready to unleash your full potential? We’re looking for people who are passionate about payments to chart Worldpay’s path to being the largest and most-loved payments company in the world. About the team Our
The Goldman Sachs Group, Inc. is a leading global investment banking, securities and investment management firm that provides a wide range of financial services to a substantial and diversified client base that includes corporations, financial institutions,
We are Reckitt そのチカラを自由に使え。 今の自分を超えていけ。 FREE YOUR POWER. PROGRESS YOURSELF. Home to the worlds best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the
職務の目的 開発品目の承認申請時の添付文書案作成等： 薬事規制及びGSKポリシーに従い、申請内容に基づく添付文書案作成においてプロジェクトチームをリードする。 CCDSに基づく添付文書の記載事項が承認されるよう、承認審査における添付文書関連照会事項に対する回答作成をリードする。 市販品目の添付文書管理： 薬事規制及びGSKポリシーに従い、最新の情報に基づく添付文書の改訂及び改訂添付文書の公開を滞りなく行う。 添付文書に係るカスタマーからの問い合わせに対して適切に回答する。 アートワーク管理： 必要な薬事Inputを行い、アートワークの変更及び製品への封入切り替えが滞りなく行われるように取り計らう。 市販後薬事： 市販品目のライフサイクルマネジメント（主にCMCの変更管理）に関連し、規制当局及び社内関連部署と良好な関係を築き、規制当局との窓口業務を適切に遂行する。 主な業務内容 承認申請資料（添付文書案含む）の作成・改訂 承認申請時の添付文書案作成における取りまとめ 承認審査時の添付文書関連照会事項に対する回答作成 添付文書改訂相談における当局窓口 添付文書改訂版の校正 添付文書の届出 PMDA 公開サイトの企業ページ管理・必要情報の登録・公開 添付文書に係る外部問合せに対する回答 患者向医薬品ガイドの作成・改訂、当局への改訂相談、公開 市販品目の変更管理に関する薬事業務 業許可管理の業務 当局対応での、承認時期への影響や承認後のグローバルビジネス及び国内での市販製品の供給への影響等を鑑みた方針決定 業界団体・学術団体等を通じた薬制に関する規制調和の推進 ライフサイクルマネジメントに関連する市販後薬事の業務全般におけるタイムライン管理、薬事的課題の把握及び解決策の提案、当局交渉等のマネジメント 必要な条件 医薬品開発、薬事関連業務、変更管理業務あるいは安全性管理業務の経験 海外とメール又は口頭でコミュニケーションができる英語力 当局関係者と交渉するためのコミュニケーション能力 基本的なITスキル（Word, Excel, Power Point等） 向上心があり、変革に対して前向きであること
