Principal Medical Writer

GENERAL SUMMARY: 

The Principal Medical Writer will support 4D‑150, a gene therapy in late-stage development for retinal vascular diseases, including nAMD and DME, and associated BLA‑enabling activities as well as clinical stage work within the lung program. This role is responsible for the planning, development, and delivery of high‑quality clinical and regulatory documents across late‑stage development, working closely with Clinical Science, Clinical Operations, Data Science, Regulatory Affairs, Quality, and external partners. This role is expected to play a central role in BLA readiness, including oversight of the development, coordination, and execution of key BLA modules, and management of internal and external medical writing resources to ensure timely, high‑quality regulatory deliverables.

The ideal candidate brings strong late clinical‑stage medical writing experience, demonstrated ability to manage complex timelines, and a deep understanding of regulatory expectations for global Phase 3 programs and BLA readiness.

MAJOR DUTIES & RESPONSIBILITIES: 

• Provide oversight for the planning, development, and execution of BLA modules, working closely with Clinical Science, Regulatory Affairs, Data Science, and Quality to ensure alignment with submission strategy and timelines.
• Lead and coordinate external medical writers and vendors, including selection, scope definition, timeline management, content review, and quality oversight.
• Ensure consistency, scientific accuracy, and regulatory alignment across BLA components and supporting clinical documents.
• Serve as a key point of integration between internal subject matter experts and external writing resources to support efficient document development and review cycles.
• Author, review, and coordinate key clinical and regulatory documents for the 4D‑150 Phase 3 program as well as for the early-phase lung program, including but not limited to protocols, protocol amendments, CSRs, IBs, DMC materials, briefing documents, and BLA‑enabling content.
• Lead document planning and timeline management in collaboration with cross‑functional teams to support aggressive development milestones.
• Ensure consistency, clarity, and scientific accuracy across clinical documents, aligning with regulatory standards and internal expectations for quality.
• Partner closely with Clinical Science, Biostatistics, and Clinical Operations to integrate data interpretations, safety narratives, and efficacy analyses.
• Manage document review cycles, address comments, and ensure timely resolution of feedback from internal stakeholders and external vendors.
• Maintain document version control and adherence to internal SOPs, templates, and quality standards.
• Contribute to continuous improvement of writing processes, tools, and templates to support scale‑up of late‑stage development activities.
• Other duties as assigned

QUALIFICATIONS: 

Education

• Advanced degree in life sciences (MS, PhD, PharmD, MD) preferred; Bachelor’s degree required.

Experience

• 5+ years of medical or clinical writing experience in biotech, pharmaceutical, or CRO settings.
• Direct experience supporting Phase 3 clinical trials required; direct experience supporting early clinical trials (Phase 1/2) preferred.
• Prior experience authoring or contributing to BLA‑enabling documents strongly preferred.

Other Qualifications / Skills

• Strong understanding of ICH guidelines, FDA regulatory expectations, and clinical development processes.
• Demonstrated ability to manage multiple complex deliverables under tight timelines.
• Excellent written communication skills with attention to scientific detail and clarity.
• Proven ability to work effectively in a fast‑paced, cross‑functional environment.
• Experience in gene therapy is a plus.
• Experience with leveraging AI-enabled tools to aid in document authoring is a plus.

Travel

• Minimal; occasional travel (<10%) as needed.

Physical Requirements and Working Conditions:

Sedentary work involving extended periods of sitting, typing, and screen use. Repetitive hand and finger movements required. Virtual meetings may occur across time zones.

Base salary compensation range: $180,000 - 202,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.