4 дня назад
Medical Writer 2 (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Medical Writer 2 (Clinical Research): Preparing complex clinical study reports, protocols, and related regulatory documents with an accent on medical writing standards, clinical data interpretation, and customer communication. Focus on leading document development, reviewing statistical analysis plans and outputs, managing timelines and budgets, and resolving quality issues across clinical research projects.
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 medical writing documents in line with SOPs, customer requirements, and agreed timelines.
- Confirm project scope, templates, specifications, review processes, and delivery schedules.
- Manage daily workloads, track project progress, implement customer requests, and identify potential risks or issues.
- Lead customer meetings, present templates or results, and negotiate timelines or resolve customer comments.
- Provide guidance to junior colleagues and deliver basic training on medical writing processes and customer templates.
- Monitor project budgets and hours, support project finance activities, and contribute to process improvements.
Requirements
- Bachelor’s degree in life sciences or a related field.
- At least 3 years of relevant experience, including significant lead-writer experience preparing clinical study reports and protocols.
- Knowledge of the structure and content requirements of clinical study reports, protocols, drug development, medical writing, and related regulations, including GCP.
- Understanding of statistical methods and the ability to review statistical analysis plans and outputs for deficiencies, errors, and inconsistencies.
- Ability to integrate, interpret, and summarize data from multiple sources clearly and accurately.
- Strong written and oral communication, attention to detail, collaboration, judgment, and ability to manage multiple projects.
Nice to have
- Master’s or Ph.D. in life sciences or a related discipline.
- Experience across multiple therapeutic areas and familiarity with medical terminology.
- Experience proposing SOP revisions or process improvements.
Culture & Benefits
- Work is performed as a full-time position within a global clinical research and healthcare organization.
- Collaboration includes customers, project leaders, project finance managers, managers, and medical writing colleagues.
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