7 дней назад
Senior Medical Writer (Clinical Research)
84 368 - 120 526$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Medical Writer (Clinical Research): Creating, reviewing, and coordinating clinical documents for independent review and regulatory submission with an accent on medical writing, clinical research standards, and document quality. Focus on managing client-facing projects, ensuring FDA/EMA and ICH-GCP compliance, and resolving complex documentation and stakeholder issues.
Location: Remote, United States. Preferred states: Arizona, Connecticut, Delaware, Florida, Georgia, Illinois, Massachusetts, Missouri, New Hampshire, New Jersey, North Carolina, Pennsylvania, Utah, and Virginia.
Annual base salary: $84,368–$120,526.
Company
supports the global biopharmaceutical industry by advancing clinical research and helping bring medical treatments to market.
What you will do
- Create, research, edit, and coordinate clinical documents for independent review, including charters, clinical data forms, case report forms, reviewer training materials, deviations, and imaging reports.
- Gather and evaluate source materials, conduct literature reviews, and prepare documents for regulatory submission and other clinical purposes.
- Serve as the primary client contact, coordinate authoring and review teams, manage timelines, and resolve project issues.
- Lead document reviews, track progress, identify risks, distribute final materials, and maintain project documentation.
- Provide medical editing and content review while ensuring document consistency, integrity, and publishing readiness.
- Support stakeholder communications, process improvements, training initiatives, and development of white papers, abstracts, posters, and manuscripts.
Requirements
- Bachelor's degree in a technical discipline; science, pharmacy, nursing, or another health-related field is preferred, or equivalent project-related experience.
- Fluent written and verbal English.
- Solid professional experience in medical writing or a similar role within clinical research, a contract research organization, pharmaceutical company, biotechnology firm, or medical communications environment.
- Experience in regulated environments, regulatory documentation, life sciences, and industry guidelines such as ICH-GCP.
- Strong written, verbal, presentation, interpersonal, critical-thinking, organizational, and negotiation skills.
- Proficiency with Microsoft Word, Excel, and PowerPoint; experience communicating project progress to stakeholders.
Nice to have
- Experience with data analysis tools such as Tableau or Power BI.
- Knowledge of Agile methodologies.
- Additional non-English language skills.
Culture & Benefits
- Remote work within the United States.
- Medical, dental, and vision coverage for employees and families.
- Flexible Spending Accounts and Health Savings Accounts.
- Paid time off, holidays, and sick time.
- 401(k), life and accident insurance, disability insurance, and internal development programs and training.
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