IQVIA Services at IQVIA

Tokyo, Japan

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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

Key technologies and capabilities for this role

Medical WritingClinical Trial ProtocolCSRCTDGCPICH GuidelinesGPSPDocument QCEnglish Medical WritingJapanese Fluency

Questions & Answers

Common questions about this position

What are the required qualifications for this Medical Writer position?

Candidates must have Medical Writing practical experience (excluding translation-only), a science university or graduate degree, foundational knowledge in pharmacy/medicine, understanding of pharmaceutical development, GCP, ICH guidelines, and Japanese regulations like GPSP, ability to read and write English (including editing English documents or translating Japanese to English with a dictionary), and fluency in Japanese.

Where is this position located?

The position is located in Shinagawa or Osaka.

What does the Medical Writing department at IQVIA offer?

The department handles a wide range of therapeutic fields from pharmaceutical companies and ventures, providing extensive document creation experience, a comprehensive internal education system, and support from in-house physicians and regulatory experts for specialized approaches.

What is the salary for this Medical Writer role?

This information is not specified in the job description.

What is the selection process for this position?

The process includes two interviews and a written test (document QC and English reading comprehension, with dictionary use allowed).

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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