Medical Writer I

**When our values align, there's no limit to what we can achieve.**   At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. **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.