Clinical Medical Writer

Working remotely as a contract Clinical Medical Writer, the candidate will develop high-quality regulatory documents for submission to Sponsors and regulatory agencies, ensuring compliance and scientific rigor. Key responsibilities: Lead the planning, development, and review of various regulatory documents, including protocols and clinical study reports Collaborate with cross-functional Sponsor teams to gather and analyze data for regulatory documents Manage project timelines and ensure all documents meet regulatory guidelines and submission deadlines Required qualifications: Bachelor's degree in a relevant scientific or medical discipline; advanced degrees (PhD, MD, or MS) preferred Minimum of 5 years of clinical regulatory writing experience in the pharmaceutical, biotechnology, or CRO environment Demonstrated expertise in authoring clinical regulatory documents, including CSRs and protocols Strong working knowledge of regulatory requirements and document structures Experience with NDA or BLA submissions preferred