Senior Medical Writer

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