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
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
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.
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
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
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
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
May compile and publish finalized medical writing deliverables
Ensure deliverables meet sponsor and regulatory standards
Bachelor’s degree preferred in:
Life Sciences
Clinical Sciences
English/Journalism
Equivalent relevant experience will be considered
5+ years of medical editing or regulatory publishing experience
Proven experience supporting global pharmaceutical clients
Deep knowledge of regulatory documents and submission standards
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)
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)
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
🔗 Apply Now
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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.
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