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 SUMMARY Responsible for soliciting and managing of reservations sales-related opportunities. Manages and provides training and work assignments to Reservations Sales staff. Actively up-sells each business opportunity to maximize revenue opportunity. Achieves personal and team related
Position Summary: Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for
Position Summary: Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for
JOB SUMMARY The position is accountable for proactively soliciting and handling sales opportunities. Ensures business is turned over properly and in a timely fashion for proper service delivery. Assists in leading all day-to-day activities related to
Req ID 68267 Yokohama-JTC, Japan Provide NPM Procurement service for the assigned locations and fulfil the procurement process Coordinate the commodity and stakeholders to implement the communication and problem solving. Manage commodity and stakeholders to carry
Company Description Company Overview Eurofins EAG Laboratories has over 40 years’ experience in materials testing services. Our parent company, Eurofins Scientific, is a multi-billion-dollar global leader in scientific services with a portfolio of over 200,000 validated
企業概要 ボッシュ株式会社 法務部は、世界市場でトップクラスの自動車部品サプライヤーであるボッシュグループの本社の法務機能の一部として、日本の法令に関わる案件の支援および日系自動車メーカーとの契約交渉などの法務業務をリードする役割を担っています。 自動車及びIT業界のメジャービジネスパートナーとの国内および海外の契約交渉や、日本の法令に関する詳細な調査・分析を通じて、法務部員として個人の専門性を高めることができます。 世界各国に所在する法務チームと連携した業務遂行や、海外のビジネス部門の活動支援を行う機会があり、国際的な業務経験を蓄積できます。また、これらの活動を通じた、ボッシュグループ全体への貢献も可能です。 The Legal Department of Bosch Corporation serves as part of the headquarters legal function of Bosch Group, a leading global automotive component supplier. It plays a role in leading legal activities
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
【Job Purpose】 Business Development Director is responsible for developing new businesses in mobile Device Lifecycle Solutions (DLS) with assigned clients, turning efforts into closure of new deals, and achieving financial goals for assigned clients. 【Primary Job
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 Overview At a global level, drive Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines to develop the informed consent form (ICF), including
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
JOB SUMMARY The position assists with the soliciting and handling of sales opportunities. Ensures business is turned over properly and in a timely fashion for proper service delivery. Assists in leading all day-to-day activities related to
JOB SUMMARY The position is accountable for proactively soliciting and handling sales opportunities. Ensures business is turned over properly and in a timely fashion for proper service delivery. Assists in leading all day-to-day activities related to
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
JOB SUMMARY The position is accountable for proactively soliciting and handling sales opportunities. Ensures business is turned over properly and in a timely fashion for proper service delivery. Assists in leading all day-to-day activities related to
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
Accepted Locations We are accepting applicants from Japan and several other countries in the region. For the full list of accepted locations, click here. This work is 100% remote. Loom Video Our Founder/CEO, Gabe Greenberg, created
JOB SUMMARY The position is accountable for proactively soliciting and handling sales opportunities. Ensures business is turned over properly and in a timely fashion for proper service delivery. Assists in leading all day-to-day activities related to
