Company Description Allegis Global Solutions is founded on a culture that is passionate about transforming the way the world acquires talent by delivering client-focused solutions that make a difference for businesses worldwide. From refining how you
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 理学系修士または同等のもの。MD、PhD、PharmD(必須ではない)
Job purpose: Responsible for implementing the Medical Affairs Plan of specified Team strategies, driving a consistent approach to carrying out scientific engagement activities internally and in the field; ensuring compliance with all relevant regulations and GSK policy/code
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 - IC2 Primary job duty is to sell technology software products and related services in
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 in
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 in
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 in
Tulip, the Frontline Operations Platform, is empowering the world’s leading manufacturers to improve the productivity of their teams, the quality of their output, and the efficiency of their operations. With Tulip’s no-code platform, manufacturers can empower
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 business applications software/solutions and related services
Requisition #: 14189 When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more than 50 years, Ansys software has enabled innovators
Requisition #: 14170 When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more than 50 years, Ansys software has enabled innovators
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
Do you enjoy a role in management? Are you interested in helping to shape a new solution in Japan About our Team Elsevier Health applies innovation, facilitates insights, and helps drive more informed decision-making for our
iA fully competent project management professional who has a broad understanding of solutions and industry best practices. This first-level project management position provides consistent creative and high quality solution leadership ensuring project quality and timely delivery
職務 概要 Position Summary : • This Job Description applies to the position of Operational Quality Group Staff at JPKK, Fuji Plant. • This individual provides quality perspective direction for all production activities at JPKK, Fuji
Microsoftでは、世界中でデータセンターを運営しており、200か所以上のデータセンター、100万以上のサーバーの管理を通して、10億人のお客様の信頼を得られるよう日々努力しております。 Microsoft Japanのデータセンターロジスティクスチームでは、チームで協力して最高のサービスをお客様に提供できるDatacenter Inventory and Asset Technician (DIAT) を募集しています。 DIATとして、Microsoftのデータセンターがクラウドサービスを中断することなく提供できるように、 安全を最優先に現場でのオペレーションを行います。チームワークを重視にし、前向きな姿勢で課題に取り組み、自分自身の成長を主体的に考え、多文化的な環境で日々現場を改善する意欲をお持ちの方からのご応募をお待ちしています。 しかしながら、関東リージョン全体をサポートするチームであるため、状況に応じて、関東リージョン内の他のエリアのサポートをしていただく日もあります。 - As a Microsoft Data Center Inventory & Asset Technician (DIAT), you will perform cycle audits, execute incoming/outgoing deliveries, coordinate security escorts for third-party
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 business applications software/solutions and related services
Job purpose Medical Science Liaison (MSL) is a field-based role in the new Medical and Development organization, reporting to MSL Head. In order to build a trust with External Experts (EE) and scientific community through, MSL needs to
Job Purpose: MSL Manager is accountable for leading and driving performance of MSL department in corresponding therapeutic area. MSL Manager drives MSL department by setting the right business objectives and priorities aligned with global counterpart to
Search Jobs Job Description The Elevator Pitch: Why will you enjoy this new opportunity? Working with the Strategic Renewals team, you will connect with and be supported by your peers and colleagues daily. As an individual,