Senior Medical Writer

Job Summary

A company is looking for a Senior Medical Writer.

Key Responsibilities:

• Author clinical study protocols, amendments, IBs, and other supporting documents while managing timelines for regulatory submissions
• Co-author CSRs and clinical/nonclinical summaries, ensuring clarity and compliance with regulatory standards
• Identify risks, contribute to process improvements, and advocate for best practices in Medical Writing

Required Qualifications:

• Bachelor's degree in a scientific discipline; advanced degree (MS, PhD, MD, PharmD) is a plus
• A minimum of 4+ years of regulatory medical writing experience in the biotech/pharmaceutical industry
• Proven experience leading the development of clinical study documents and regulatory submissions
• Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements
• Proficiency in word processing software and document management systems