Principal Medical Writer
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Job Description
Principal Medical Writer authoring clinical and regulatory documents for Iambic Therapeutics’ AI-driven drug-discovery programs. Leading IND submissions and cross-functional medical-writing workflows.
Responsibilities:
- Plan, author, and deliver submission-ready documents, including protocols, IBs, DSURs, CSRs, INDs, Health Authority responses, and briefing documents
- Independently lead cross-departmental document development with Clinical, Nonclinical, Medical, Biostatistics, CMC, and Regulatory teams
- Represent medical writing on internal cross-functional study teams and ad hoc working groups
- Support abstracts, posters, and presentations for scientific conferences
- Establish and refine medical writing processes, templates, and standards
- Implement and manage efficient document workflows and timelines
- Participate in evaluating and integrating AI-enabled tools to improve writing quality and efficiency
- Report to the Head of Medical Writing
- Contribute to Iambic Therapeutics’ mission of developing differentiated, patient-optimized therapeutics through AI-driven drug discovery and development
Requirements:
- Bachelor’s degree in a life science or health-related field required
- Advanced degree (Master’s, PhD, or PharmD) preferred
- Minimum 10 years of relevant medical writing experience
- Demonstrated experience with IND submissions and documents supporting clinical-stage programs
- Excellent scientific writing, communication, and organizational skills
- Highly skilled in Microsoft Office suite, particularly MS Word
- Experience with electronic document and reference management systems preferred
- Aptitude and interest in learning and adopting new technologies, including AI-enabled tools
- Strong understanding of FDA/EMA regulations and ICH guidelines
- Comfortable working and collaborating in a fast-paced environment
- Must be currently authorized to work in the United States
- Must not require visa sponsorship now or in the future
Benefits:
- Company-paid healthcare
- Flexible spending accounts
- Voluntary life insurance
- 401(k) matching
- Uncapped vacation
- Onsite gym
- Onsite dining
- Brand-new state-of-the-art facility in San Diego
- Easy access to great places to live and play
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