Senior Clinical Medical Writer

Job Summary

Seeking an experienced Senior Clinical Medical Writer for a full-time remote position, responsible for developing high-quality regulatory documents for clinical studies, ensuring compliance with regulatory guidelines, and collaborating with cross-functional teams.

Key responsibilities:

• Lead the planning, development, and review of regulatory documents, including protocols and clinical study reports
• Collaborate with cross-functional Sponsor teams to gather and analyze data for regulatory submissions
• Ensure all clinical regulatory documents are compliant with regulatory guidelines and company SOPs

Required qualifications:

• Bachelor's degree in a relevant scientific or medical discipline; PhD, MD, or MS preferred
• Minimum of 5 years of clinical regulatory writing experience in the pharmaceutical, biotechnology, or CRO environment
• Expertise in authoring clinical regulatory documents, including protocols and clinical study reports
• Strong working knowledge of regulatory requirements and document structures
• Proficiency in Microsoft Word and document management systems