Job Title: Senior Medical Writer
Company: Eikon Therapeutics
Locations: Jersey City, NJ; New York City, NY; Millbrae, CA
Department: Medical Writing / Clinical Development
Company Overview
Eikon Therapeutics is a pioneering biopharmaceutical company combining chemistry, engineering, computation, and biology to discover life-saving drugs. Founded by Nobel Prize-winning scientists, Eikon has developed revolutionary real-time single-molecule tracking microscopes that unlock novel drug targets previously considered undruggable.
Role Summary
As a Senior Medical Writer, you will independently lead the development of high-quality clinical and regulatory documents, supporting Eikon’s clinical programs. This role involves cross-functional collaboration and requires strong scientific writing, project management, and regulatory document expertise.
Work Location Requirement
Hybrid Onsite: Minimum 3 days/week onsite at one of Eikon’s offices (Jersey City, NYC, or Millbrae).
Must be able to work on-site more frequently as needed for collaboration and team growth.
Key Responsibilities
Author and edit a broad range of clinical and regulatory documents, including protocols, CSRs, IBs, CTD modules (2.5, 2.7.x, 5), briefing documents, abstracts, posters, and manuscripts
Interpret scientific and clinical data for clear, compliant, and audience-appropriate presentation
Independently manage document lifecycles including planning, drafting, reviews, QC, and finalization
Drive cross-functional collaboration to align on timelines and deliverables
Ensure documents meet internal standards and regulatory guidelines (e.g., ICH, GCP)
Proactively contribute to process improvements within the medical writing function
Perform or support document QC, template standardization, and structured content reuse
Qualifications
Education:
Ph.D., M.D., or Pharm.D. preferred
OR Master’s with 3+ years OR Bachelor’s with 5+ years of relevant experience in clinical/regulatory medical writing
Experience:
Clinical protocol and CSR writing required
Familiarity with CTD and regulatory submissions
Experience interpreting clinical data and statistics for documentation
Skills:
Proficiency with Microsoft Office, Adobe Acrobat, and collaborative tools (e.g., SharePoint, Veeva, PleaseReview)
Familiarity with EndNote, Prism, PerfectIt, and structured content management is a plus
Excellent written, verbal, and project management skills
Knowledge of FDA regulations, GCP, ICH guidelines is a strong asset
Compensation & Benefits
Salary Range: $125,000 – $136,800 (commensurate with experience and market)
Bonus & Equity: Eligible
Benefits Include:
95% covered medical and 100% covered dental/vision insurance
401(k) with company match
Generous paid time off + weeklong summer and winter shutdowns
Mental health & wellness programs
Daily subsidized lunches (on-site)
Enhanced parental leave
Life and AD&D insurance (100% company-paid)
Application Notice
Eikon is not accepting resumes from third-party agencies at this time.
All applications must go through official channels.
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