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Job Overview
Location
Remote - US
Job Type
Full-time
Category
Product Management
Date Posted
May 22, 2026
Full Job Description
đź“‹ Description
- • Lead the planning, authoring, and delivery of key regulatory development documents including INDs, protocols, investigator brochures (IBs), clinical study reports (CSRs), health authority responses, and briefing documents.
- • Provide strategic input on document content, messaging, and regulatory expectations to align with global submission goals.
- • Partner cross-functionally with Clinical, Nonclinical, Medical, Biostatistics, CMC, and Regulatory teams to ensure timely and accurate document development.
- • Establish, refine, and implement scalable medical writing processes, templates, and quality standards to support current and future pipeline programs.
- • Manage end-to-end document workflows and timelines to meet regulatory submission deadlines in a fast-paced, clinical-stage environment.
- • Support the development of scientific abstracts, posters, and presentations for presentation at international conferences.
- • Evaluate, integrate, and optimize AI-enabled tools to enhance writing efficiency, consistency, and quality across all deliverables.
- • Manage external medical writing vendors and oversee vendor performance, deliverables, and cost-efficiency.
- • Build internal medical writing capabilities over time, including recruitment, training, and team development as the function scales.
- • Ensure consistency, accuracy, and regulatory compliance across all medical writing outputs globally.
- • Advise cross-functional leadership on regulatory communication strategy and global document planning to support IND submissions and clinical-stage programs.
- • Drive the adoption of fit-for-purpose documentation standards that align with FDA, EMA, and ICH guidelines.
- • Maintain high standards of scientific writing and editing with meticulous attention to detail and regulatory requirements.
- • Balance strategic leadership responsibilities with hands-on authoring and editing of critical regulatory documents.
- • Contribute to the company’s mission of accelerating drug discovery through AI-driven innovation by enabling timely regulatory submissions.
🎯 Requirements
- • Bachelor’s degree required; advanced degree (PhD, PharmD, MD) preferred
- • 15+ years of experience in biotech/pharma, with 10+ years specifically in medical writing
- • Prior experience in smaller or growing biotech environments preferred
- • Strong experience supporting IND submissions and clinical-stage programs
- • Strong scientific writing and editing skills with exceptional attention to detail
- • Solid understanding of FDA/EMA regulations and ICH guidelines
🏖️ Benefits
- • Industry-leading competitive pay
- • Company-paid healthcare
- • Flexible spending accounts
- • Voluntary life insurance
- • 401K matching
- • Uncapped vacation
Skills & Technologies
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About Iambic Therapeutics, Inc.
Iambic Therapeutics is a biotechnology company leveraging a cutting-edge, AI-driven platform to revolutionize drug discovery and develop superior medicines. Utilizing physics-based AI algorithms and high-throughput experimental processes, Iambic addresses challenging design problems to generate optimized drug candidates and explore novel mechanisms of action. Their platform-driven pipeline focuses on first-in-class and best-in-class programs, including a HER2 program already in Phase 1 clinical studies, aimed at unlocking the potential of known targets and transforming undruggable targets into breakthrough treatments for patients with unmet medical needs. This innovative approach enables them to deliver differentiated clinical candidates at an accelerated pace, supported by over $100 million raised in an oversubscribed financing round to advance their portfolio.
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