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
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