Job Purpose: クローバルメディカルライティング及び国内マトリックスチームと協働し、規制当局に提出する承認申請資料、臨床試験の関連文書等の作成をリードする。関連法規、ガイドライン及び社内規定に従い、戦略的に、正確で科学的な文書を遅滞なく作成し、臨床試験の実施及び承認申請・取得に貢献する。また、効率的な文書作成プロセスを推進する。 Key Accountabilities/Responsibilities: 規制当局に提出する薬事文書の作成のリード:CTDの臨床・臨床薬理パート、対面助言資料、照会事項回答等 臨床試験に関連する文書の作成:治験実施計画書、治験総括報告書等 上記文書の作成におけるストラテジー・key messageの作成、文書作成のファシリテート、解析計画等の検討、スケジュールの作成及びCROマネジメント等 Basic Qualification: Skill CTD臨床パート、治験総括報告書、治験実施計画書等、承認申請や臨床試験に関連する文書の作成能力 社内外の関係者と円滑にコミュニケーションし、マトリックスチームをリードすることができる Global Medical Writing と協業するための英語でのコミュニケーションスキル ロジカルシンキング ダイナミックな変化のある状況下において、柔軟性・自発性をもって問題解決能力を発揮し、目標に向かって推進できる能力 臨床試験に関する基本的知識 生物統計学、薬物動態学に関する基本的知識 薬事規制、ICHガイドライン等に関する基本的知識 基本的なPCスキル(Word、Excel、PDF) Experience 製薬企業又はCROにおけるメディカルライティング業務経験(3年以上) Preferred Qualification: Skill 英文メディカルライティングスキル(治験総括報告書、治験実施計画書等) Experience 承認申請及び審査対応業務の経験(CTD作成、照会事項対応) 臨床開発業務又はそれに準ずる業務経験 複数部署の関係者で構成されるチームをリードした経験 Education/Certification/Language 薬学部または理学系学部卒以上
Job Purpose ViiV will reinforce the capability of data analysis and sales force effectiveness. Within the Business Intelligence & Analytics team, the role will focus on sale force design, targeting/call allocation and performance tracking including sales
企業概要 シーカは、建築分野や自動車産業における接着、シーリング、制振、補強、保護のための革新的なシステムや製品の開発・生産で世界をリードする特殊化学品会社として、世界的に認知されています。世界101カ国に子会社を持ち、300以上の工場を持つシーカは、全世界で33,000人以上の従業員を擁し、2022年度の売上高は105億スイスフランでした。日本では、シーカは長い歴史を持ち、1200人以上の専門家からなる献身的なチームを擁しています。 求人内容 Job Purpose 1. Management one or more Categories (certain groupings of Direct and/or Indirect spend items) within a country 2. Development Category strategies and commercial tactics for assigned category 3. Management of suppliers
Our Company Changing the world through digital experiences is what Adobe’s all about. We give everyone—from emerging artists to global brands—everything they need to design and deliver exceptional digital experiences! We’re passionate about empowering people to
企業概要 IFS is a billion-dollar revenue company with 6000+ employees on all continents. We deliver award winning enterprise software solutions through the use of embedded digital innovation and a single cloud-based platform to help businesses be
As a Senior Systems Manager, you have the opportunity to add to that legacy by being a part of the construction process from start to finish by utilizing your knowledge to drive successful completion of 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
PGIM is the diversified asset management business of Prudential Financial, Inc. (NYSE: PRU). With $1.29 trillion in assets under management, and 45 offices spanning 18 countries, PGIM is among the world’s top-14 largest asset managers. Each
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
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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
Job purpose: Plan and execute the marketing strategy and tactics to ensure commercial success of the product Key responsibilities: To strategically drive “Shape the market” & “Shape the product”, work with Brand Lead to develop and
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
An exciting opportunity as an Operation Specialist at a leading global logistics company. Some of the responsibilities involve order processing of Shippers Own Tanks (Round-Trip Operations) and handling of import and export orders for local customers.
* Manage logistics activities for ongoing windfarm construction projects * Collaborate with logistics vendors to ensure smooth import/export process of heavy machinery and spare parts items Client Details Our client is a multinational company that is