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Senior Medical Writer

3-5 years
$125,000 – $136,800
10 May 5, 2025
Job Description
Job Type: Full Time Hybrid Education: Ph.D., M.D., or Pharm.D Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.