5 часов назад
Medical Writer-KunTuo (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Medical Writer-KunTuo (Clinical Research): Leading the preparation of complex clinical study reports, protocols, and related medical writing documents with an accent on regulatory compliance, statistical interpretation, and customer collaboration. Focus on reviewing statistical analysis plans and outputs, identifying inconsistencies, managing timelines and budgets, and guiding junior medical writers.
Location: Shanghai, China
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Lead the preparation of complex clinical study reports, protocols, and other assigned medical writing documents.
- Confirm project scope, templates, specifications, timelines, document reviews, and customer requirements.
- Manage daily workload, track project progress, implement customer requests, and escalate risks or issues.
- Lead customer meetings and present templates, results, lessons learned, or related project information.
- Provide basic training and guidance to colleagues; support junior medical writers.
- Monitor project budgets and hours, contribute to financial activities, and support process improvements.
Requirements
- Bachelor’s degree in life sciences or a related field.
- At least 3 years of relevant experience, including significant experience as a lead writer for clinical study reports and protocols.
- Knowledge of clinical study report and protocol structure, drug development, medical writing, regulations, medical terminology, and Good Clinical Practice.
- Understanding of statistical methods used in clinical trials, including the ability to review statistical analysis plans and outputs.
- Ability to integrate, interpret, and clearly summarize data from multiple sources while identifying errors and inconsistencies.
- Excellent written and oral communication, attention to detail, collaboration, independent judgment, and multitasking skills.
Nice to have
- Master’s or Ph.D. degree in life sciences or a related field.
- Experience providing presentations, training, or guidance to colleagues.
- Experience managing small, short-term medical writing projects.
Culture & Benefits
- Work within a global organization supporting the development and commercialization of medical treatments.
- Collaborate with customers, project leaders, project finance managers, managers, and medical writing colleagues.
- Operate according to standard operating procedures and customer-specific requirements.
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