Senior Medical Writer

A company is looking for a Senior Medical Writer - Regulatory & Publications. Key Responsibilities Prepare and develop high-quality regulatory and publication documents, including clinical study reports and study protocols Lead project team meetings and provide direction on document content and strategies Ensure compliance with regulatory standards and mentor less experienced medical writers Required Qualifications Bachelor's degree in a science-related field with 7+ years of relevant industry experience, or a master's degree with 5+ years of experience in medical writing or related areas Experience in NDA submissions and writing regulatory documents such as CSRs and IBs Proven experience writing scientific medical publications, including journal manuscripts and abstracts Strong scientific background in oncology, immunotherapy, or a related field Proficient knowledge of AMA writing guidelines and extensive knowledge of FDA, EMA, and ICH guidelines