Medical Writer I

Job description

**Job Summary** We are looking for a Medical Writer I to support the preparation, review, and delivery of clinical and regulatory documents. The ideal candidate will have a strong scientific background, excellent writing skills, and an understanding of clinical research and drug development processes. **Key Responsibilities** - Author, edit, and review clinical and regulatory documents, including: Clinical Study Reports (CSRs), Interim Study Reports, Informed Consent Forms (ICFs), Safety Update Reports, Patient Narratives - Conduct literature searches and scientific reviews to support document development. - Analyze and interpret clinical study data to prepare high-quality scientific content. - Ensure compliance with ICH-GCP guidelines, SOPs, templates, and regulatory requirements. - Perform quality checks to ensure data accuracy, consistency, and document integrity. - Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs. - Support document review cycles, manage timelines, and address stakeholder feedback. **Skills** - Strong clinical and scientific writing skills. - Good understanding of clinical research, drug development, and regulatory guidelines. - Experience with medical writing, clinical documentation, or medical communications. - Excellent written and verbal communication skills. - Strong attention to detail and organizational skills. - Proficiency in Microsoft Word, Excel, SharePoint, and document management systems. - Ability to manage multiple projects and work effectively in a collaborative environment. **Qualifications** - Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or related healthcare discipline. - Experience within a CRO, pharmaceutical, biotechnology, healthcare, or medical communications organization preferred. #LI-REMOTE