Regulatory Medical Writer

Job Summary

Leading the scientific and clinical regulatory writing efforts, the contract Regulatory Medical Writer - QC Reviewer will work remotely to develop submission-ready documents and perform quality control reviews while collaborating with clinical and regulatory teams.

Key responsibilities

• Contribute to timeline planning and manage the document review/approval process for regulatory and clinical documents
• Collaborate with team members to gather and compile information for scientific, clinical, and regulatory document development
• Ensure compliance with applicable guidelines and regulations while preparing manuscripts and other scientific publications

Required qualifications

• A graduate degree in life sciences or paramedical sciences with 5 years of relevant writing experience, or a bachelor's degree with over 5 years of writing experience in the biotechnology/pharmaceutical industry
• Expertise in Microsoft Word, Adobe Acrobat, Veeva, and reference-management software
• Thorough understanding of the drug-development process and expertise with CTD document content and templates
• Strong writing skills with knowledge of style guides and ability to assist colleagues with software
• Certification from industry-recognized Medical Writing associations is preferred