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
Sells a subset of product or services directly or via partners to a large number of named accounts/non-named accounts/geographical territory. Career Level - IC3 Primary job duty is to sell technology software products and related services
Objectives of Position: Independently or partially independently execute R&D projects and topics that support the BASF innovation pipeline to meet the current and future business needs for BASF. Main Areas of Responsibilities and Key Activities: Accelerate Innovation
Account Manager This role has been designed as ‘’Onsite’ with an expectation that you will primarily work from an HPE partner/customer office. Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way
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 be
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 be
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Sales Job Details About Salesforce We’re Salesforce, the Customer
JOB SUMMARY Functions as the leader of the property’s sales department for properties with bookings over 300 peak rooms and significant local catering revenue. Manages the propertys reactive and proactive sales efforts. Provides day to day
Acquia empowers the world’s most ambitious brands to create digital customer experiences that matter. With open source Drupal at its core, the Acquia Digital Experience Platform (DXP) enables marketers, developers, and IT operations teams at thousands
Job Description: ■Mission Empowering people and society through payment innovation. We, the sales team of Rakuten Payments, are at the forefront of creating this message that the company is aiming for. Rakuten Groups business model is called
JOB SUMMARY Leads and manages all day-to-day activities related to the sales function with a focus on building long-term, value-based customer relationships that enable achievement of property sales objectives. Achieves personal booking goals and makes recommendations
Location Kasumigaseki Building 33rd Floor - 3-2-5 Kasumigaseki, Brookfield Culture Brookfield has a unique and dynamic culture. We seek team members who have a long-term focus and whose values align with our Attributes of a Brookfield
What you will do The Senior Category buyer is responsible for project spend for APAC region. Responsibilities include supplier scouting, selection, supplier management, price & contract negotiations, drive product optimization and working capital management. The buyer
It’s an amazing time to be joining Netflix as we continue to transform entertainment globally. Netflix is the worlds leading internet entertainment service with over 270 million paid memberships in over 190 countries enjoying TV series,
Account Executive - Enterprise - Japan Rapid7 is seeking a curious, customer centric and target driven Account Executive to join our Japan sales team and be responsible for all aspects of new customer acquisition across the territory,
JOB SUMMARY Responsible for overseeing and coordinating the revenue management functions (pricing, competitive assessments, etc.) and recommending inventory strategy for participating Franchise hotels across all brands in Japan. This includes all room segments (transient, group, and
Industrial Engineer - Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000428728 Date Posted: 2024-06-10 Location: JPN - Nagoya, Japan, JPN - Tokyo, Japan Job Description Qualifications: Boeing Supply Chain GFO Industrial Engineering is looking for
EDP Renewables APAC is the main subsidiary of EDP Group, a global leader in the renewable energy sector and one of the world’s largest wind producers. With its headquarters in Singapore, EDP Renewables is the leading
The Opportunity As a Sales Representative, you will focus on generating new business across all of Morningstar’ s main product lines and will be reporting to Head of Sales, Asia and Managing Director, Southeast Asia. Although you will
Job Purpose Background: Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. To achieve our ambitious