Instagram
youtube
Facebook

Senior Medical Editor (Editing And Qc Of Regulatory Docs)

5 years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Hybrid Education: Bachelor’s degree preferred in Life Sciences, Clinical Sciences, English, Journalism, or related field Equivalent combination of education and relevant experience also considered 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)

πŸ“ Location: Gurugram, India (Hybrid)
πŸ†” Job ID: 25100736
πŸ“… Updated On: August 22, 2025
πŸ•’ Employment Type: Full-time
✈️ Travel: Minimal


πŸ”Ž About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions provider, offering clinical, medical affairs, and commercial capabilities. With over 29,000 employees in 110 countries, we help bring new therapies to market faster and more effectively.

🌐 Learn more: www.syneoshealth.com


πŸ’Ό Position Summary

As a Senior Medical Editor, you will play a critical role in editing and performing quality control (QC) on regulatory and scientific documents. This includes clinical study protocols, CSRs, Investigator’s Brochures, manuscripts, posters, abstracts, and more—ensuring they meet both internal quality standards and global regulatory requirements.


πŸ”§ Key Responsibilities

πŸ“˜ Editorial & Quality Review

  • Perform copyediting on regulatory and publication documents, ensuring:

    • Correct grammar, punctuation, spelling, tense, and style

    • Compliance with AMA or sponsor-specific style guides

  • Conduct data integrity reviews to ensure accuracy and consistency of content

  • Review documents such as:

    • Clinical study protocols & amendments

    • Clinical Study Reports (CSRs)

    • Investigator’s Brochures

    • Module 2 clinical summary documents

    • Manuscripts, posters, abstracts

πŸ” Project & Process Management

  • Serve as project lead for complex/large medical writing projects

  • Track project timelines and budgets; escalate delays or risks as needed

  • Schedule and lead internal editorial meetings

  • Ensure accurate dissemination of requirements to editorial teams

  • May compile and publish regulatory documents

πŸ§‘‍🏫 Training & Mentorship

  • Mentor and train junior editors and medical writers on:

    • Editing and QC practices

    • Data integrity checks

    • Publishing standards

  • Advise writing teams on formatting, regulatory compliance, and style

  • Provide cross-functional guidance on editorial best practices

βš™οΈ Process Improvement

  • Contribute to:

    • Development of internal SOPs, checklists, and editorial standards

    • Process improvement tools and initiatives across the medical writing department


πŸŽ“ Qualifications & Skills

Education:

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

  • Equivalent combination of education and relevant experience also considered

Experience:

  • Minimum 5 years of medical editing and regulatory publishing experience

  • Significant experience editing documents for global pharmaceutical clients

Technical Skills:

  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)

  • Strong familiarity with Adobe Acrobat and/or other markup tools

  • Experience with ISI Toolbox (preferred)

  • Knowledge of FDA, EU, and ICH regulatory document standards

  • Excellent understanding of AMA style guide (strongly preferred)

Soft Skills:

  • Exceptional attention to detail and accuracy

  • Strong project management and multitasking skills

  • Excellent communication and interpersonal abilities

  • Ability to work independently and collaboratively in a deadline-driven environment

  • Flexible and adaptable to changes in responsibilities and work duties


🎯 Why Join Us

  • Access to global clinical and regulatory projects

  • Culture focused on development, mentorship, and internal mobility

  • Part of an inclusive and diverse global organization

  • Work that directly contributes to the approval of life-changing therapies


πŸ“₯ How to Apply

πŸ”— Apply for this job
🌐 Not ready to apply? Join our Talent Network


πŸ“ Additional Information

  • This job description is not exhaustive. Other tasks may be assigned as needed.

  • Equivalent experience or transferable skills will be considered.

  • Syneos Health complies with ADA, EEOC, and EU Equality Directives, and provides reasonable accommodations when appropriate.


πŸ‘€ Recently Viewed Jobs

  • Safety & PV Ops Specialist I

  • Senior Medical Writer

  • Medical Writer I