Instagram
youtube
Facebook

Senior Medical Editor (Editing And Qc Of Regulatory Docs)

5+ years years
Not Disclosed
10 Aug. 29, 2025
Job Description
Job Type: Hybrid Education: Bachelor’s degree (preferred) in: Life Sciences Clinical Sciences English / Journalism OR equivalent experience in copyediting, publishing, or data integrity review 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 – Gurugram (Hybrid)
Updated: August 22, 2025


🧬 About Syneos Health

Syneos Health® is a fully integrated, global biopharmaceutical solutions organization that partners with clients to accelerate their success. With 29,000 employees across 110 countries, we combine clinical, medical, and commercial capabilities to bring therapies to patients faster.

“WORK HERE MATTERS EVERYWHERE”


💼 Why Join Us?

  • 🌐 Global exposure with leading pharmaceutical clients

  • 📈 Career development, mentorship, and technical training

  • 🧘 Commitment to the Total Self culture: authenticity, diversity, and inclusion

  • 🎖 Recognition and total rewards program

  • 🤝 Collaborative and purpose-driven teams


🔍 Job Overview

As a Senior Medical Editor, you will be responsible for editing, quality control, and publishing of regulatory and clinical documents. You'll also provide editorial guidance, support cross-functional teams, and lead projects in a hybrid working environment.


🎯 Key Responsibilities

✏️ Editing & Quality Control

  • Perform copyediting and data integrity (QC) on documents such as:

    • Clinical Study Protocols and Amendments

    • Clinical Study Reports (CSRs)

    • Investigator’s Brochures (IBs)

    • Module 2 Clinical Summaries

    • Publications: manuscripts, posters, abstracts

  • Ensure alignment with AMA Manual of Style and custom sponsor style guides

  • Ensure documents meet FDA, EU, ICH, and internal submission standards

👥 Team Leadership & Project Support

  • Serve as a project lead on large/complex medical writing projects

  • Schedule and lead team meetings, manage editorial project timelines, and allocate resources

  • Represent the editorial team on cross-functional and study-specific teams

  • Provide feedback to medical writers and support their document preparation process

📘 Documentation & Publishing

  • Manage documentation in compliance with SOPs and client-specific guidelines

  • May support compiling and publishing of regulatory deliverables

  • Track timelines and budgets; report risks to leads and project managers

  • Contribute to SOPs, process enhancements, and internal tool development

📚 Training & Mentoring

  • Mentor junior editors and support their professional development

  • Deliver training on editorial standards and regulatory compliance

  • Advise teams on publishing tools, document quality, and best practices


✅ Required Qualifications

Education

  • Bachelor’s degree (preferred) in:

    • Life Sciences

    • Clinical Sciences

    • English / Journalism

  • OR equivalent experience in copyediting, publishing, or data integrity review

Experience

  • Minimum 5+ years of medical editing experience

  • Hands-on experience editing regulatory documents and scientific publications

  • Experience working with global pharma/CRO clients

Technical Skills

  • Strong copyediting and publishing experience using:

    • Adobe Acrobat (or similar markup tools)

    • Microsoft Office Suite (Word, Excel, PowerPoint)

    • ISIToolbox (preferred)

  • Proficient in:

    • Grammar, formatting, style consistency, and document QC

    • AMA Style Guide (extensive familiarity preferred)


🧠 Competencies

  • Strong attention to detail

  • Ability to handle multiple projects with minimal supervision

  • Excellent written and verbal communication skills

  • Organized, adaptable, and deadline-driven

  • Collaborative mindset with ability to work independently and in teams

  • Understanding of FDA, EU, ICH, and ISO standards is a plus


🌍 Additional Information

  • Responsibilities may evolve as per business needs

  • Equivalent education/experience considered

  • No employment contract implied

  • Compliance with ADA and EU Equality Directive ensured


📬 How to Apply


🌈 Diversity & Inclusion Commitment

At Syneos Health, we value authenticity and believe in the power of diverse thoughts, backgrounds, and perspectives. Even if your experience doesn’t perfectly match the role, we encourage you to apply. Transferable skills and varied paths are welcomed.