シニアメディカルライター – IQVIA Services

This is a fully remote position, open to applicants in Japan.

📋 Description

• Creation and review of clinical trial-related documents (including study protocols, clinical study reports, and Common Technical Documents).

• Development and review of amendments to global study protocols to meet Japanese requirements.

• Preparation and review of clinical research and PMS-related documents (such as study plans, safety periodic reports, and papers).

• Management of project progress, personnel, budget, and client relations.

• Mentoring junior staff and other related tasks.

⛳️ Requirements

• Over 5 years of experience in Medical Writing (translation only is not acceptable).

• Graduate degree from a science-related university or graduate school.

• Understanding of pharmaceutical development, GCP, and ICH-related guidelines.

• Knowledge of domestic regulatory affairs related to pharmaceuticals.

• Foundational knowledge in pharmacology, medicine, and statistics.

• English proficiency: capable of reading and writing (able to review and edit English documents, translate from English to Japanese, and compose English reports); preferred TOEIC score of 730 or higher, conversational ability at a daily conversation level.

• Fluency in Japanese is required.

• Experience in clinical pharmacology is a plus (analysis not necessarily required).

🏝️ Benefits

• Comprehensive benefits package including both statutory (social insurance system) and non-statutory (IQVIA's unique system) offerings.

• Measures against passive smoking are in place.

• Annual paid leave, summer vacation, sick leave, special leave, maternity leave, childcare and caregiving leave, nursing leave, among others.