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Senior Medical Writer

3+ years
$125,000 – $136,800
10 May 5, 2025
Job Description
Job Type: Full Time Hybrid Education: Ph.D., M.D., PharmD 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

Company Overview

Eikon Therapeutics is a biopharmaceutical company leveraging cutting-edge technology that combines chemistry, engineering, computation, and biology. Their discovery platform, founded on Nobel Prize-winning innovations (2014), enables real-time, molecular-resolution tracking of proteins in living cells—unlocking previously inaccessible drug targets.


Role Summary

As a Senior Medical Writer, you will lead the creation of clinical and regulatory documents. You will collaborate with cross-functional teams to ensure the timely delivery of high-quality, accurate content supporting Eikon’s clinical portfolio. A hybrid schedule with a minimum of 3 days onsite weekly is required at one of the listed office locations.


Key Responsibilities

  • Independently author and edit clinical and regulatory documents, including:

    • Clinical protocols, CSRs, IBs

    • CTD modules (2.7.x, 2.5, Module 5 summaries)

    • Briefing books, posters, abstracts, manuscripts

  • Interpret scientific data and ensure documents meet regulatory standards

  • Manage document timelines and workflow

  • Lead document-related meetings and resolve content-related issues

  • Perform quality control reviews and ensure consistency across documents

  • Contribute to ongoing process improvements


Qualifications

  • Education:

    • Doctorate (Ph.D., M.D., PharmD) preferred

    • Master’s with 3+ years or Bachelor’s with 5+ years of relevant experience

  • Experience:

    • Strong background in medical/regulatory writing

    • Clinical study protocol writing experience preferred

    • Understanding of GCP, ICH guidelines, and clinical development phases

  • Skills:

    • Excellent writing, communication, and project management skills

    • Familiarity with Microsoft Office, SharePoint, Veeva RIM, GraphPad Prism, etc.

    • Knowledge of statistical concepts

    • Structured content management familiarity preferred


Compensation & Benefits

  • Salary range: $125,000 – $136,800, based on experience

  • Equity and bonus compensation

  • 401k with company match

  • Health insurance (95–100% premiums covered)

  • Paid time off, parental leave, and wellness benefits

  • Daily subsidized lunch (on-site)

  • Summer and winter holiday shutdowns


Application Information

  • Resume/CV required

  • Cover Letter optional

  • Must be authorized to work in the U.S.

  • Must accept terms of Eikon’s Non-Disclosure Agreement