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Senior Medical Editor – Editing And Qc Of Regulatory Documents

5 years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Remote Education: Bachelor’s degree preferred in: Life Sciences Clinical Sciences English/Journalism Equivalent relevant experience will be 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

Senior Medical Editor – Editing and QC of Regulatory Documents

📍 Location: Remote (India)
🆔 Job ID: 25100736
📅 Updated On: August 22, 2025
💼 Employment Type: Full-Time
🏢 Company: Syneos Health


🔍 About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization supporting clinical, medical affairs, and commercial development for clients worldwide. We are a team of 29,000+ professionals across 110 countries, driven to accelerate therapies that improve lives.

Learn more: www.syneoshealth.com


💼 Position Summary

As a Senior Medical Editor, you will ensure the quality, accuracy, and regulatory compliance of medical and regulatory documents by performing editing, formatting, and data integrity reviews. You will work cross-functionally with medical writers and study teams, serving as a subject matter expert in editing standards and submission guidelines.


🧩 Key Responsibilities

✍️ Document Editing & Quality Control

  • Copyedit clinical and regulatory documents for:

    • Grammar, punctuation, and spelling

    • Formatting and consistency (e.g., tense, units)

    • Style compliance using AMA or client-specific guidelines

  • Perform data integrity reviews to ensure accuracy and logical flow

  • Review a wide range of documents including:

    • Clinical Study Protocols & Amendments

    • Clinical Study Reports (CSRs)

    • Investigator’s Brochures

    • Module 2 Clinical Summaries

    • Manuscripts, Posters, Abstracts

📊 Project & Stakeholder Management

  • Serve as the project lead on complex or large editorial deliverables

  • Monitor project timelines and budgets, alerting leads to risks or delays

  • Attend and lead internal project-specific meetings

  • Collaborate closely with:

    • Lead Medical Writers

    • Project Managers

    • Cross-functional teams and editorial staff

🧠 Mentorship & Training

  • Train and mentor junior editors and medical writers on:

    • Editing techniques

    • Data QC

    • Publication and submission standards

  • Advise study teams on editorial and publishing best practices

  • Represent the editorial team on cross-functional projects and meetings

⚙️ Process Improvement

  • Support the development and refinement of:

    • Internal SOPs

    • Style guides

    • Editorial checklists and best practices

  • Contribute to initiatives that enhance process efficiency and editorial consistency

📂 Publishing

  • May compile and publish finalized medical writing deliverables

  • Ensure deliverables meet sponsor and regulatory standards


🎓 Qualifications & Experience

Education

  • Bachelor’s degree preferred in:

    • Life Sciences

    • Clinical Sciences

    • English/Journalism

  • Equivalent relevant experience will be considered

Experience

  • 5+ years of medical editing or regulatory publishing experience

  • Proven experience supporting global pharmaceutical clients

  • Deep knowledge of regulatory documents and submission standards

Technical Skills

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

  • Skilled in Adobe Acrobat or similar markup tools

  • Familiarity with ISI Toolbox preferred

  • Strong command of AMA Style Guide (extensive familiarity preferred)


🧠 Core Competencies

  • High attention to detail and accuracy

  • Excellent written and verbal communication

  • Strong organizational and time management skills

  • Ability to manage multiple projects independently

  • Adaptable to changing responsibilities and fast-paced environments

  • Knowledge of FDA/EU/ICH/ISO guidelines relevant to regulatory documentation (preferred)


💡 Why Join Syneos Health?

  • Global exposure with top-tier pharmaceutical clients

  • Career development and internal mobility opportunities

  • Inclusive culture based on our Total Self philosophy

  • Recognition programs and comprehensive benefits

  • 94% involvement in FDA-approved novel drugs in the past 5 years


📥 How to Apply

🔗 Apply Now
📬 Not ready to apply? Join our Talent Network


🔒 Additional Information

  • This job description outlines core responsibilities but is not exhaustive.

  • Other duties may be assigned at the company’s discretion without prior notice.

  • Syneos Health provides reasonable accommodations for candidates with disabilities in accordance with the Americans with Disabilities Act (ADA) and EU Equality Directive.