Join Iambic Therapeutics as a Principal Medical Writer to lead the development of high-quality submission-ready documents for clinical-stage programs.
Posted by employer 2 months ago
First seen on Joblaze 2 months ago
Last verified on the company career page 5 hours ago
Skills & Technologies
AI in the day-to-day
Participate in the evaluation and integration of AI-enabled tools to improve writing quality and efficiency.
Requirements
Not disclosed in this posting: compensation, visa sponsorship.
Benefits
Joblaze summary
The Principal Medical Writer at Iambic Therapeutics plays a crucial role in crafting and overseeing the development of high-quality, submission-ready documents essential for clinical-stage programs and IND submissions. This position requires expertise in regulatory writing, a strong grasp of FDA/EMA regulations, and proficiency in Microsoft Office, particularly MS Word, along with a willingness to adopt new technologies. Ideal candidates will have over ten years of medical writing experience and a background in life sciences, thriving in a fast-paced, collaborative environment. Iambic, a clinical-stage company founded in 2020, emphasizes innovation through AI-driven drug discovery and values
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From the original posting
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
Bold. We are courageous, take thoughtful risks, and approach challenges with tenacity.
Standard company text repeated across Iambic Therapeutics's postings is omitted here.