Medical Writer

Summary

Join Generate:Biomedicines, a leading biomedicines company, as a highly skilled Medical Writer Contractor. This remote, part-time (15-20 hours/week) role focuses on regulatory writing for a 6-month contract. You will develop and author critical regulatory documents, collaborating with cross-functional teams. The ideal candidate possesses extensive experience in medical and regulatory writing within the biotechnology or pharmaceutical industry, including nonclinical writing. A strong understanding of ICH guidelines and regulatory requirements is essential. This position requires excellent writing and analytical skills and the ability to manage multiple projects effectively. The role offers flexibility with remote work, occasional travel to the Somerville, MA office as needed.

Requirements

• Minimum 10 years of experience in the biotechnology or pharmaceutical industry
• At least 8 years of experience in medical writing with a strong emphasis on regulatory writing
• Extensive experience with nonclinical writing, including contributions to nonclinical study reports and nonclinical regulatory documentation
• Strong knowledge of ICH guidelines and regulatory requirements for global regulatory submissions
• Excellent writing, editing, and analytical skills with a proven ability to translate complex scientific data into well-structured, regulatory-compliant documents
• Ability to work independently, manage multiple projects, and meet tight deadlines in a fast-paced environment

Responsibilities

• Develop and author high-quality regulatory and scientific documents
• Collaborate cross-functionally with regulatory, clinical, and nonclinical teams to ensure accuracy and alignment of scientific and regulatory content
• Interpret complex scientific data and present it in a clear, concise, and regulatory-compliant manner
• Ensure adherence to regulatory guidelines (ICH, FDA, EMA, etc.), company standards, and industry best practices
• Support regulatory submission activities by preparing high-quality documents in compliance with electronic submission requirements

Preferred Qualifications

• Advanced degree in life sciences (PhD, PharmD, or MS)
• Experience with document management systems (e.g., Veeva, eCTD submissions)

Benefits

Remote work