Lead Medical Writer for IND Submissions & Regulatory Docs

Iambic; San Diego (CA); On-site; USD 152,000 - 190,000; Full time

Job summary

Iambic Therapeutics is seeking a Principal Medical Writer to independently author and oversee submission-ready documents supporting clinical-stage programs and IND submissions.

Reporting to the Head of Medical Writing, this role will partner with cross-functional stakeholders to advance Iambic’s mission of delivering highly differentiated, patient-optimized therapeutics to address urgent unmet medical needs.

Qualifications

• Bachelor’s degree in life sciences required; advanced degree preferred with 10+ years of medical writing experience.
• Experience with IND submissions and documents to support clinical-stage programs.
• Strong scientific writing abilities and familiarity with regulatory guidelines (FDA/EMA).

Responsibilities

• Plan, author, and deliver submission-ready documents (protocols, IBs, DSURs, CSRs, INDs, Health Authority responses, briefing documents).
• Independently lead cross-departmental document development with Clinical, Nonclinical, Medical, Biostatistics, CMC, and Regulatory teams.
• Represent medical writing on internal study teams and ad hoc groups.
• Support development of abstracts, posters, and conference presentations.
• Help establish medical writing processes, templates, and standards; manage workflows and timelines.

Skills

Regulatory writing

Medical writing

Cross-functional collaboration

AI-enabled tools

MS Word proficiency

Education

Bachelor’s degree in life sciences

Advanced degree (Masters/PhD/PharmD) preferred

Tools

MS Word

Electronic document management systems

AI-enabled tools

Job description

Iambic Therapeutics is seeking a Principal Medical Writer to independently author and oversee submission-ready documents supporting clinical-stage programs and IND submissions.

Reporting to the Head of Medical Writing, this role will partner with cross-functional stakeholders to advance Iambic’s mission of delivering highly differentiated, patient-optimized therapeutics to address urgent unmet medical needs.