
Posted 21 days ago
Principal Medical Writer
AI Summary
The Principal Medical Writer independently authors and oversees submission-ready regulatory documents (protocols, IBs, DSURs, CSRs, INDs, and Health Authority responses) for clinical-stage programs, collaborating with cross-functional teams and helping refine medical writing processes and AI-enabled tools.
About this role
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.
Skills
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