Principal Medical Writer

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

Job Summary

Iambic Therapeutics is seeking an experienced Principal Medical Writer to independently author and oversee development of high-quality submission-ready documents to support clinical-stage programs and IND submissions.

Job Summary

Iambic Therapeutics is seeking an experienced Principal Medical Writer to independently author and oversee development of high-quality submission-ready documents to support 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. The ideal candidate will have strong scientific judgment, regulatory writing expertise, and the ability to thrive in a fast-moving, evolving organization.

Key Responsibilities

• Responsible for planning, authoring, and delivery of submission-ready documents (protocols, IBs, DSURs, CSRs, INDs, Health Authority responses, and briefing documents etc.)
• Independently lead cross-departmental document development by collaborating with the 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
• Help establish and refine medical writing processes, templates, and standards to ensure consistency, quality, and accuracy across all deliverables. Implement and manage efficient document workflows and timelines
• Participate in the evaluation and integration of AI-enabled tools to improve writing quality and efficiency

Qualifications

• Bachelor’s degree in a life science (or health-related field) required; advanced degree (Masters/PhD/PharmD) preferred with a minimum 10 years of relevant medical writing experience
• 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. Experience with electronic document and reference management systems preferred, with a demonstrated 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

About Iambic Therapeutics

Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at iambic.ai.

MISSION & CORE VALUES

Our mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.

Pay And Benefits

We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.

Compensation Range: $152K - $190K