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Senior Medical Editor (Editing And Qc Of Regulatory Docs)

5+ years years
Not Disclosed
10 Aug. 29, 2025
Job Description
Job Type: Remote Education: Bachelor’s degree preferred in Life Sciences, Clinical Sciences, English, Journalism 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 (Editing and QC of Regulatory Docs)

Job ID: 25100736
Location: IND – Remote
Updated: August 22, 2025


🧬 About Syneos Health

Syneos Health® is a leading, global, fully integrated biopharmaceutical solutions organization. We collaborate with pharmaceutical, biotech, and medical device companies to accelerate their success by integrating clinical development, medical affairs, and commercial services.

  • 29,000 employees across 110 countries

  • Supported 94% of all FDA Novel Drug Approvals in the last 5 years

  • Delivered 200+ studies at over 73,000 sites involving 675,000+ patients

Motto: WORK HERE MATTERS EVERYWHERE


💡 Why Join Us?

  • 🚀 Career advancement opportunities and internal mobility

  • 🧠 Learning & development programs and peer recognition

  • 🧘 Total Self culture – encouraging authenticity and well-being

  • 🌍 Diverse, inclusive, and collaborative environment

  • 🛠️ Work on impactful global projects with top-tier pharmaceutical clients


🎯 Key Responsibilities

✍️ Editorial Oversight & Quality Control

  • Perform editing and data QC on regulatory and scientific documents, including:

    • Clinical Study Protocols and Amendments

    • Clinical Study Reports (CSRs)

    • Investigator's Brochures (IBs)

    • Module 2 Clinical Summaries

    • Publications (manuscripts, posters, abstracts)

  • Ensure compliance with sponsor style guides and regulatory submission standards

  • Apply AMA Manual of Style or custom style guides, ensuring correct grammar, punctuation, spelling, and formatting

📑 Project Management & Team Collaboration

  • Lead or support complex, large-scale medical writing projects

  • Organize project-specific editorial requirements and timelines

  • Communicate progress to medical writers, project managers, and stakeholders

  • Represent the editorial team in study/project team meetings and cross-department initiatives

  • Provide feedback to lead medical writers on the editorial process and document readiness

🧠 Subject Matter Expertise & Mentoring

  • Maintain familiarity with FDA, EMA, ICH, and ISO regulatory standards

  • Conduct training and mentoring for junior medical editors and medical writers

  • Serve as a technical resource for editorial best practices and publishing standards

  • Contribute to process improvements, SOP updates, and development of editorial tools


🧠 Required Qualifications & Skills

🎓 Education:

  • Bachelor’s degree preferred in Life Sciences, Clinical Sciences, English, Journalism, or a related field

  • Relevant copyediting, publishing, or data integrity review experience may substitute for education

✅ Experience:

  • Minimum 5+ years of experience in medical editing, copyediting, or regulatory publishing

  • Strong knowledge of editing regulatory documents and scientific publications

  • Experience working with global pharmaceutical or CRO clients

  • Familiarity with regulatory documents and terminology

🔧 Technical Skills:

  • Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)

  • Skilled in Adobe Acrobat, markup languages, or publishing tools (ISIToolbox preferred)

  • Deep understanding of AMA style and other regulatory editing standards

  • Familiarity with FDA and EU guidelines and submission formatting standards

🤝 Soft Skills:

  • Exceptional attention to detail and editorial accuracy

  • Strong grammar, communication, and organizational skills

  • Ability to work independently and manage multiple projects under tight deadlines

  • Team player with a collaborative mindset and adaptability to changing priorities


📌 Additional Information

  • Responsibilities may evolve as per company needs

  • Equivalent education or experience may be considered

  • This posting does not constitute an employment contract

  • Syneos Health is an Equal Opportunity Employer and ADA compliant


📬 How to Apply


🌍 Diversity & Inclusion Commitment

We encourage candidates from diverse backgrounds to apply—even if your experience doesn’t perfectly align. Transferable skills and fresh perspectives are valued. Let’s grow together.