シニアメディカルライター（Sr. Medical Writer/ IQVIA Services） at IQVIA

Tokyo, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, Clinical ResearchIndustries

Requirements

Medical Writing experience 5+ years (translation only not acceptable)
Degree from science university or graduate school
Understanding of pharmaceutical development, GCP, ICH guidelines
Knowledge of domestic pharmaceutical regulations
Basic knowledge of pharmacy/medicine/statistics
English skills: reading/writing (able to review/edit English documents, translate English to Japanese, create English reports), TOEIC 730+ recommended, conversational English at daily level
Fluency in Japanese

Responsibilities

Creation and review of clinical trial-related documents (investigator's brochure, clinical study report, common technical document)
Creation and review of revisions to global trial investigator's brochures to meet Japanese requirements
Creation and review of clinical research/PMS-related documents (protocols, periodic safety reports, publications, etc.)
Project progress management, personnel management, budget management, client correspondence
Guidance and mentoring of junior staff

Skills

Key technologies and capabilities for this role

Medical WritingClinical Trial ProtocolsCSRsCTDPMS ReportsICH GuidelinesGCPJapanese Drug RegulationsEnglish Technical WritingProject ManagementStaff Mentoring

Questions & Answers

Common questions about this position

Is remote work available for this position?

Yes, the position allows full remote work nationwide.

What are the required qualifications for this Senior Medical Writer role?

Candidates must have 5+ years of Medical Writing experience (not just translation), a science university or graduate degree, understanding of drug development, GCP, ICH guidelines, domestic pharmaceutical regulations, basic knowledge in pharmacology/medicine/statistics, English reading/writing skills (TOEIC 730+ equivalent), and fluency in Japanese.

What is the salary and compensation structure?

Salary is determined according to company regulations with favorable treatment, and includes raises and bonuses.

What benefits and work-life support does IQVIA offer?

Benefits include both statutory social insurance and IQVIA's own comprehensive schemes, flex time, telework system, passive smoking measures, and various holidays such as annual paid leave, summer vacation, sick leave, special leave, women's special leave, childcare/caregiving leave, and nursing leave.

What is the application process for this role?

The process is fully online: 1) Submit resume and work history, 2) Document screening, 3) Written test & HR interview (online, 2h15m), 4) Department interviews (manager 30min + director 1h, same day or adjusted). A 6-month trial period applies.

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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