Senior Medical Writer

Job Summary

To support the expansion of a biotech company, the full-time Senior Medical Writer will provide medical writing support for developing complex clinical, nonclinical, and safety documents for regulatory submissions while working remotely.

Key responsibilities

• Author and project manage content for regulatory submissions, ensuring compliance with medical writing standards
• Develop phase 1-4 protocols, master ICFs, IBs, and CSRs, while maintaining inspection-readiness of medical writing activities
• Collaborate with project teams to meet deadlines and execute corporate objectives and strategies

Required qualifications

• Bachelor's degree in a scientific or clinical discipline; Ph.D. preferred
• Minimum of 3 years of sponsor-level pharma or biotech clinical/regulatory medical writing experience
• Fluent in American English, with strong writing and communication skills
• Experience with Veeva Vault and Please Review, along with lean writing techniques
• Basic understanding of scientific methodology in drug development and familiarity with pharmacovigilance guidelines