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。
企業概要 AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several
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
Are you an experienced medical professional and passionate about Medical Affairs? Are you a dynamic leader with a passion for driving MSL team? If so, we have an exciting opportunity for you to join our team as a
Company Description Company Overview Third Bridge is a market-leading investment research firm. We provide integrated solutions for the world’s top investors and business leaders to help them make smarter and faster decisions. No other company in
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
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
Are you an experienced medical professional and passionate about Medical Affairs? Are you a dynamic leader with a passion for driving MSL team? If so, we have an exciting opportunity for you to join our team as a
Are you an experienced medical professional and passionate about Medical Affairs? Are you a dynamic leader with a passion for driving MSL team? If so, we have an exciting opportunity for you to join our team as a
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 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
Job Description The Security Compliance Team at Zendesk supports the business by maturing, growing, and maintaining its compliance with security and privacy certifications for its products. Our mission is to strengthen Zendesks security posture and empower
* The Safety Management Officer will oversee all safety management and pharmacovigilance (PV) activities in Japan. * This role involves ensuring compliance with local regulations, managing risk, and maintaining high standards of safety for all products.
* Lead and manage a team of biostatisticians and data managers to ensure the delivery of high-quality and timely statistical analysis plans, data management plans, and data analyses for clinical trials. Client Details * Our client
* At the front line of communication with stakeholders at hospital sites / clinics, youll manage clinical aspects of full-service global trial projects. Your responsibilities will include ensuring timelines, targets, and standards are met for clinical
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
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
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
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
