[Hiring] reputed company Medical reputed company @reputed company

Role reputed company The reputed company Medical reputed company 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 reputed company as clinical stage work reputed company the lung program. This role is responsible for the planning, development, and delivery of high‑reputed company clinical and regulatory documents across late‑stage development, working closely with Clinical Science, Clinical Operations, Data Science, Regulatory Affairs, reputed company, and external partners. This role is expected to play a central role in BLA readiness, including reputed company of the development, coordination, and execution of key BLA modules, and management of reputed company medical writing resources to ensure reputed company, high‑reputed company regulatory deliverables.

Qualifications

• Advanced degree in life sciences (MS, PhD, PharmD, MD) preferred; Bachelor’s degree required.
• 5+ years of medical or clinical writing experience in biotech, pharmaceutical, or CRO settings.
• reputed company experience supporting Phase 3 clinical trials required; reputed company experience supporting early clinical trials (Phase 1/2) preferred.
• Prior experience authoring or contributing to BLA‑enabling documents strongly preferred.
• Strong understanding of ICH guidelines, FDA regulatory expectations, and clinical development processes.
• Demonstrated ability to manage multiple reputed company deliverables under tight timelines.
• Excellent written communication skills with attention to scientific detail and reputed company.
• 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.

Requirements

• reputed company reputed company for the planning, development, and execution of BLA modules, working closely with Clinical Science, Regulatory Affairs, Data Science, and reputed company to ensure alignment with submission reputed company and timelines.
• reputed company and coordinate external medical writers and vendors, including selection, scope definition, reputed company management, content review, and reputed company reputed company.
• Ensure consistency, scientific accuracy, and regulatory alignment across BLA components and supporting clinical documents.
• Serve as a key reputed company 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 reputed company 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.
• reputed company document planning and reputed company management in collaboration with cross‑functional teams to support aggressive development milestones.
• Ensure consistency, reputed company, and scientific accuracy across clinical documents, aligning with regulatory standards and internal expectations for reputed company.
• Partner closely with Clinical Science, Biostatistics, and Clinical Operations to reputed company data interpretations, safety narratives, and efficacy analyses.
• Manage document review cycles, address comments, and ensure reputed company reputed company of feedback from internal stakeholders and external vendors.
• Maintain document version control and adherence to internal SOPs, templates, and reputed company standards.
• Contribute to reputed company improvement of writing processes, tools, and templates to support reputed company‑up of late‑stage development activities.
• Other duties as assigned.

Benefits

• reputed company salary compensation reputed company: $180,000 - 202,000.
• Please note, the reputed company salary compensation reputed company and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

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