Medical Writer - Clinical Regulatory

Job Summary

Collaborating with cross-functional teams, the full-time Medical Writer - Clinical Regulatory Documentation will prepare and deliver high-quality, scientifically accurate clinical documents for regulatory submissions while working remotely.

Key responsibilities

• Author clinical documents, including protocols, study reports, and investigator brochures, ensuring scientific accuracy and regulatory compliance
• Work closely with clinical development and regulatory affairs teams to meet project objectives and timelines
• Participate in the review and revision of clinical documents based on feedback from stakeholders and regulatory bodies

Required qualifications

• 5-8 years of experience in medical writing within the pharmaceutical, biotechnology, or clinical research industry, preferably in oncology
• Familiarity with global regulatory requirements for clinical documentation (e.g., FDA, EMA, ICH)
• Strong understanding of clinical trial processes and regulatory submissions
• A Bachelor's degree in a life sciences discipline; a Master's or Ph.D. is preferred
• Experience with writing for regulatory submissions (INDs, NDAs/BLAs/MAAs) is highly preferred