Principal Medical Writer

The role

The Principal Medical Writer will independently author and oversee development of submission-ready documents to support clinical-stage programs and IND submissions. This role partners with cross-functional stakeholders to advance the company mission.

What you will do

• Plan, author, and deliver submission-ready documents including protocols, IBs, DSURs, CSRs, INDs, Health Authority responses, and briefing documents.
• Lead cross-departmental document development by collaborating with Clinical, Nonclinical, Medical, Biostatistics, CMC, and Regulatory teams.
• Represent medical writing on internal cross functional study teams and ad hoc working groups.
• Support development of 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 the evaluation and integration of AI-enabled tools.

Required qualifications

• Bachelor's degree in a life science (or health-related field)
• Demonstrated experience with IND submissions and documents to support clinical-stage programs
• Detail-oriented with excellent scientific writing, communication, and organizational skills
• Highly skilled in Microsoft Office suite, particularly MS Word
• Strong understanding of FDA/EMA regulations and ICH guidelines
• Comfortable working and collaborating in a fast-paced environment

Nice to have

• Advanced degree (Masters/PhD/PharmD)
• Minimum 10 years of relevant medical writing experience
• Experience with electronic document and reference management systems
• Aptitude and interest in learning and adopting new technologies, including AI-enabled tools

Benefits

• Company-paid medical coverage
• Flexible spending accounts
• Voluntary life insurance
• 401(k) matching
• Flexible time off
• Community gym
• Dining

About the company

Iambic Therapeutics (Nasdaq: IAM) is a technology and clinical-stage life sciences company headquartered in San Diego. The company utilizes molecular superintelligence to address the totality of drug discovery and development.