CSR Narrative Writer - Project Based (Remote)

Please note that this is a Project-based opportunity requiring up to 40 hours per week support until the end of July 2026 Roles and Responsibilities Responsible for writing safety documents intended for submission to regulatory agencies. Responsible for writing patient CSR narratives and producing high quality documents. Practices excellent internal and external customer service. Good understanding of MS Word for advanced writing techniques. Address client comments during document lifecycle, manage revisions, and review deliverables with limited mentor oversight prior to releasing to client. Ensure documents comply with appropriate ICH and regulatory guidelines. Interact directly and independently with client. Ability to follow MMS and sponsor processes. Practices internal and external leadership skills. Requirements Experience in leading complex CSR narratives projects, preference for Oncology background. College graduate in scientific, medical, clinical discipline or related field, or related experience. Prior medical/ narrative/ safety writing experience preferred; Interested in expanding knowledge of drug development as it pertains to narrative writing. Master’s or PhD in a scientific, medical, or clinical discipline preferred. 2-3 years’ experience with regulated scientific/clinical or pharmaceutical, biotech or clinical research environment. Understands ICH guidelines, as applicable to writing for clinical studies. Excellent written English skills. High degree of organization and able to manage multiple projects at any given time. Attention to detail and committed to excellence in all aspects of their work. Excellent communication and interpersonal skills. Proficient in Microsoft Word and Adobe Acrobat. Experience in the use of an Electronic Document Management system. Should you not have received a response within 14 days of your application, please consider your application unsuccessful.