Principal Medical Writer

Iambic Therapeutics, Inc

$135K — $160K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's in life science; advanced degree preferred (Masters/PhD/PharmD)
  • Minimum 10 years of medical writing experience
  • Experience with IND submissions and clinical-stage documents
  • Excellent writing, communication, and organizational skills
  • Proficient in Microsoft Office, especially MS Word; familiarity with electronic document systems preferred
  • Strong knowledge of FDA/EMA regulations and ICH guidelines
  • Ability to thrive in fast-paced environments

Responsibilities

  • Plan, author, and deliver submission-ready documents
  • Lead cross-departmental document development
  • Represent medical writing on internal study teams
  • Support development of scientific abstracts and presentations
  • Establish and refine medical writing processes and standards
  • Manage efficient workflows and timelines for document delivery
  • Integrate AI-enabled tools to enhance writing quality

Benefits

  • Company-paid healthcare
  • Flexible spending accounts
  • Voluntary life insurance
  • 401K matching
  • Uncapped vacation
  • State-of-the-art facility with onsite gym and dining
  • Access to great living and recreational options in San Diego
Full 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. 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 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.

Similar Jobs

More Jobs at Iambic Therapeutics, Inc

More Pharmaceuticals & Biotech Jobs

Find similar Principal Medical Writer jobs: