Medical Writer

Cambridge, MA
Development /
Full-Time /
On-site
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