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） 職務内容および勤務地の変更範囲は会社の定めるところとする。
Job Description:We are seeking a highly capable and innovative Freelance Medical Writer and Copy Lead to join our dynamic team. This role blends deep scientific understanding and excellent writing skills with an emphasis on medical communications across a diverse
Planate Management Group (PMG) is a Service-Disabled Veteran-Owned Small Business (SDVOSB) headquartered in Alexandria, Virginia, and Orlando, Florida USA with technical support centers in South East Asia and East Africa, that provides program management and facilities
Our clients Microsoft Business Solutions team is a Microsoft Gold Partner and leader in Microsoft software implementations for medium to large organisations, providing their clients with the ability to keep up with the ever-changing digital world
Our clients Microsoft Business Solutions team is a Microsoft Gold Partner and leader in Microsoft software implementations for medium to large organisations, providing their clients with the ability to keep up with the ever-changing digital world
Microsoft is on a mission to empower every person and every organization on the planet to achieve more. Our culture is centered on embracing a growth mindset, a theme of inspiring excellence, and encouraging teams and
Requisition #: 14327 Internal Job Title: Technical Support Engineer Job Level: P1 Hiring Mgr: Yuichiro Hiyoshi External Job Title: Technical Support Engineer : Electromagnetics Business Unit: ANSYS Customer Excellence Recruiter: Masamichi Tanaka Our Mission: Powering Innovation
About NetApp We’re forward-thinking technology people with heart. We make our own rules, drive our own opportunities, and try to approach every challenge with fresh eyes. Of course, we can’t do it alone. We know when
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
Cybersecurity Engineering & Operations Advisor - Secureworks - Tokyo, Japan or Remote Secureworks (NASDAQ: SCWX) is a global cybersecurity leader that secures human progress with Secureworks® Taegis, a SaaS-based, open XDR platform built on 20+ years
Responsibilities: About the Company Tencent is a leading global technology company focused on connecting people and developing innovative products and services that improve the quality of life of people around the world. Founded in 1998 and
Requisition #: 14370 Our Mission: Powering Innovation That Drives Human Advancement 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
About Us Wellington Management offers comprehensive investment management capabilities that span nearly all segments of the global capital markets. Our investment solutions, tailored to the unique return and risk objectives of institutional clients in more than
Requisition #: 14370 Our Mission: Powering Innovation That Drives Human Advancement 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
Job Profile SummaryJob Overview Responsible for management and service delivery excellence for assigned projects, covering single or multiple Lifecycle Safety functions (clinical trial and / or post-market). Provide leadership and accountability for customer-facing activities and oversight
About Klick HealthMeet a different kind of workplace. Klick Health is an ecosystem of brilliant minds working to realize the full potential of their people and clients in life sciences since 1997. And we’re still growing
Join us today and make a difference in peoples lives! Position Summary - The country Commercial Quality Specialist is part of the commercial organization. The main activities of this position are: a. Designated Safety Manager for
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
Who we are looking for An individual who is energetic, collaborative, proactive and works well within a team. FX Operations Tokyo works closely with FX Sales Tokyo to support their business. As part of FX Operations
At Gensler, we design for people. We leverage our global perspective and local presence to innovate at every scale. We’re not just designers. We’re tinkerers, craftspeople, visionaries, innovators and thought leaders. Fueled by passion and entrepreneurial
