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
Seniority level
Not Applicable
Employment type
Full-time
Job function
Marketing, Public Relations, and Writing/Editing
Industries
Biotechnology Research
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