Clinical Medical Writer

Job Summary

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