Medical Writer/ MW/ IQVIA Services at IQVIA

Tokyo, Japan

IQVIA Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Healthcare, Clinical ResearchIndustries

Requirements

  • Medical Writing実務経験がある(翻訳のみの方は対象外)
  • 理系大学、大学院卒
  • 薬学・医学的な基礎知識を有する
  • 医薬品開発全般、GCP、ICH関連ガイドライン、国内薬事規制(GPSP等)を理解している
  • 英語の読み書きが可能(辞書を使って英文書の添削や和文英訳が可能なレベル)
  • Fluency in Japanese would be required

Responsibilities

  • 臨床試験関連文書(治験実施計画書、治験総括報告書、コモンテクニカルドキュメント等)の作成
  • グローバル試験の治験実施計画書に対して日本要件を満たすための修正版の作成
  • 製造販売後調査関連文書(安全性定期報告、再審査申請資料等)の作成
  • 臨床研究報告書・論文の作成
  • 各種文書のQC

Skills

Medical Writing
Clinical Trial Protocol
CSR
CTD
GCP
ICH Guidelines
GPSP
Document QC
English Medical Writing
Japanese Fluency

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters
1998Year Founded
$3,526MTotal Funding
POST_IPO_EQUITYCompany Stage
Cybersecurity, Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.
Proliferation of disparate technological solutions causes technology overload in clinical trials.
Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.
The company offers privacy-enhancing technologies to protect individual patient data.
IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.
AI-driven drug discovery accelerates identification of potential drug candidates.
Expansion of telemedicine facilitates remote patient monitoring and data collection.

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