About this role
4DMT is a leading late-stage biotechnology company advancing durable therapeutics for retinal vascular diseases and cystic fibrosis. The Principal Medical Writer supports 4D-150, a gene therapy in late-stage development for nAMD and DME, plus BLA-enabling activities and lung program work. This role plans, develops, and delivers high-quality clinical and regulatory documents.
Responsibilities include oversight of BLA modules, coordination of external writers, and ensuring consistency across documents. The writer authors protocols, CSRs, IBs, and briefing documents for Phase 3 programs. Close collaboration occurs with Clinical Science, Operations, Data Science, Regulatory Affairs, and Quality teams.
Works cross-functionally with internal experts and external partners to manage timelines and reviews. Integrates subject matter input for efficient document cycles. Partners with Biostatistics and Clinical Operations for alignment.
Plays a central role in BLA readiness, managing resources for timely deliverables. Ideal for those with late clinical-stage experience and regulatory knowledge. Supports aggressive milestones in global Phase 3 programs.
Requirements
- Strong late clinical-stage medical writing experience
- Demonstrated ability to manage complex timelines
- Deep understanding of regulatory expectations for global Phase 3 programs
- Experience with BLA readiness and module development
- Ability to ensure scientific accuracy and regulatory alignment in clinical documents
- Proficiency in authoring protocols, protocol amendments, CSRs, and IBs
- Skill in coordinating cross-functional teams and external vendors
Responsibilities
- Provide oversight for the planning, development, and execution of BLA modules
- Lead and coordinate external medical writers and vendors, including selection and timeline management
- Ensure consistency, scientific accuracy, and regulatory alignment across BLA components
- Serve as a key point of integration between internal subject matter experts and external resources
- Author, review, and coordinate key clinical and regulatory documents including protocols, CSRs, IBs, and BLA content
- Lead document planning and timeline management in collaboration with cross-functional teams
- Partner closely with Clinical Science, Biostatistics, and Clinical Operations
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