Medical Writer

Company Mission

At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.

Position Summary

eGenesis is seeking a Medical Writer to develop high-quality, technically accurate documents to support regulatory filings for our xenotransplantation programs. The Medical Writer will play a crucial role in our liver, kidney, and heart programs, specifically in preparing PIND/IND and Expanded Access applications. The successful candidate will work closely with cross-functional teams, including researchers, clinicians, regulatory affairs, and project managers, to develop comprehensive and scientifically rigorous applications.

Primary Responsibilities

• Develop and write high-quality, scientifically accurate documents for regulatory filings, including preclinical and clinical study reports, protocols, investigator brochures, and regulatory submission documents
• Ensure all documents comply with regulatory requirements and guidelines
• Collaborate with subject matter experts (SMEs) to gather, interpret, and synthesize complex scientific data
• Facilitate communication between cross-functional teams to ensure alignment and clarity in the documentation process
• Manage timelines and deliverables for multiple writing projects, ensuring timely completion
• Coordinate with program management lead to align writing activities with overall project milestones
• Conduct thorough reviews and revisions of documents to ensure accuracy, consistency, and completeness
• Implement quality control processes to ensure documents meet high standards of excellence
• Provide regulatory writing support and expertise during audits and inspections
  
  
  

QUALIFICATIONS

• Minimum of 3-5 years of medical writing experience in the biotechnology or pharmaceutical industry, with a focus on gene therapy
• Proven experience in preparing and submitting IND applications, expanded access applications, and other regulatory documents
• Exceptional scientific writing and editing skills, with a strong ability to convey complex scientific concepts clearly and concisely
• In-depth knowledge of regulatory requirements and guidelines for drug development and approval processes
• Excellent project management and organizational skills, with the ability to manage multiple projects and meet tight deadlines
• Strong interpersonal and communication skills, with the ability to work effectively in a collaborative team environment