**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** + Solid 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 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
📌 Medical Writer I (India)
🏢 Parexel
📍 India