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 Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world
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
As a Microsoft Data Center Inventory & Asset Technician (DIAT), you will perform cycle audits, execute incoming/outgoing deliveries, coordinate security escorts for third-party vendors, and document inbound and outbound deliveries as instructed by management. You will
About Zscaler Zscaler (NASDAQ: ZS) accelerates digital transformation so that customers can be more agile, efficient, resilient, and secure. The Zscaler Zero Trust Exchange is the company’s cloud-native platform that protects thousands of customers from cyberattacks
As a Field Marketing Manager for Oracles Cloud Applications, you will be responsible for crafting and executing event marketing plans targeting the ERP and HCM sectors. This role requires a collaborative team player who can work
The Contracts Administrator job is comprised of either a Deal Specialist or a Deal Manager role. Both work in a multi-cultural environment and cover multiple countries and/or lines of business. The work is fast-paced and seasonal
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
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
At Qualtrics, we create software that the world’s best brands use to deliver exceptional frontline experiences, build high-performing teams, and design products people love. But we are more than a platform. We are the creators and
Have you created the perfect music playlist? Apply to this opportunity today! ModSquad has partnered with a top music streaming service and we are currently seeking music-lovers and experienced Customer Support Representatives to join our team.
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The Difference You Will Make As an US Military Services
Would you like to be a part of a content team focused on the medical industry? Want to take your nursing experience and knowledge to the next level of publishing? About our Team Elsevier is a global
International SOS is the world’s leading medical and security services company with over 12,000 employees working in 1,000 locations in 90 countries. International SOS Government Services administers the TRICARE Overseas Program providing high-quality, accessible health care services
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
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
Company Description Headquartered in Bethesda, Maryland, ISN Corporation is a nationwide provider of specialized professional services to Federal government agencies. ISNs portfolio includes work with over 100 Federal agencies. ISN Corporation has been awarded a place
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
