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Senior Medical Editor

5+ years
Not Disclosed
10 Jan. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Editor
Location: United States, Remote

About the Role:
As a Senior Medical Editor, you will join the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. You will play a key role in ensuring the highest quality of clinical documents by performing comprehensive reviews and edits, adhering to submission standards and style guides.

What You Will Be Doing:

  • Document Quality Control:
    Perform quality control (QC) review of clinical study protocols, amendments, clinical study reports (CSRs), Investigator's Brochures, and select Module 2 clinical summary documents. Ensure documents comply with the Incyte Style Guide and submission standards.

  • Data Verification and Formatting:
    Verify data in documents against source tables, figures, and listings, and format tables according to Incyte standards.

  • Proofreading and Copyediting:
    Copyedit and proofread clinical documents for grammar, style, and formatting in accordance with AMA and Incyte style guides. Ensure internal consistency and that data are reported accurately, with statements reflecting source documents or data (e.g., SAS tables and listings).

  • Reference and Citation Management:
    Check reference lists in documents, verify citation information against PubMed, order copies of references, and add them to the electronic document management system (EDMS). Ensure each reference is properly cross-referenced within the document.

  • Publishing and Process Improvement:
    May assist with publishing nonclinical and clinical documents, compiling CSR appendices, and participating in process improvement initiatives.

  • Collaboration with Medical Writing:
    Assist Medical Writing staff with other tasks as needed, contributing to seamless document preparation.

You Are:

  • Qualifications:

    • Bachelor’s degree in English, Basic Science, Business, or another analytical field, with 2 years of related experience in the pharmaceutical industry, or 5+ years of experience in a related discipline (e.g., medical writing, QC, editing, publishing).
    • Proficient in Microsoft Word, including formatting tables, inserting cross-references, applying styles, and using templates. Experience with PowerPoint, Excel, Visio, and Adobe is preferred.
    • Experience with an EDMS (e.g., Veeva Vault or SharePoint).
  • Skills:

    • Keen attention to detail and accuracy.
    • Ability to manage multiple activities and prioritize effectively in a fast-paced, deadline-driven environment.
    • Strong verbal, written, and interpersonal communication skills.

What ICON Can Offer You:
ICON is committed to fostering a diverse and inclusive culture that rewards high performance and nurtures talent. In addition to a competitive salary, we offer a wide range of benefits designed to enhance well-being and support work-life balance for you and your family:

  • Various annual leave entitlements.
  • A range of health insurance options tailored to your needs.
  • Competitive retirement planning offerings.
  • Global Employee Assistance Program, TELUS Health, offering 24-hour access to over 80,000 specialized professionals.
  • Life assurance and flexible country-specific benefits, including childcare vouchers, bike purchase schemes, gym memberships, and more.

Why ICON?
At ICON, diversity, inclusion, and belonging are essential to our values. Our commitment to inclusivity drives innovation and helps us better serve our employees, patients, customers, and communities. We are dedicated to providing an inclusive and accessible environment for all candidates.