Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Senior Medical Editor (Qc /Editing Of Reg Docs)

Syneos Health
Syneos Health
6-9 years
preferred by company
10 Feb. 5, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 – Regulatory Documents QC & Editing

Updated: February 3, 2026
Location: Gurgaon, Haryana, India
Job ID: 25104158-OTHLOC-5206-2DH
Employment Type: Full-time

About Syneos Health

Syneos Health® is a leading global biopharmaceutical solutions organization, uniquely positioned to accelerate customer success. By integrating clinical development, medical affairs, and commercial expertise, Syneos Health delivers end-to-end solutions that address today’s evolving market realities.

With a strong patient-centric Clinical Development model, the organization continuously innovates to simplify processes, enhance collaboration, and deliver therapies faster. Operating across more than 110 countries with a workforce of over 29,000 professionals, Syneos Health is committed to improving lives worldwide.

Position Overview

The Senior Medical Editor – Regulatory Documents QC & Editing is responsible for ensuring the quality, accuracy, and regulatory compliance of clinical and regulatory documents through advanced editorial review, data integrity checks, and publishing support. This role provides senior-level editorial expertise, mentors junior editors, and leads quality control activities for complex and large-scale regulatory deliverables.

Key Responsibilities

  • Maintain expert-level knowledge of FDA, EMA, ICH, and other global regulatory guidelines to ensure compliance with sponsor and regulatory requirements

  • Perform comprehensive copyediting and quality control of regulatory and clinical documents, ensuring adherence to AMA style and sponsor-specific style guides

  • Conduct detailed data integrity reviews to ensure accuracy, consistency, and completeness of clinical and regulatory content

  • Serve as the editorial representative on medical writing teams, study teams, and cross-functional project groups

  • Lead editorial activities for complex or large regulatory deliverables, including coordination of multiple editors

  • Monitor project timelines and deliverables, proactively escalating risks to Lead Medical Writers or Project Managers

  • Provide expert guidance to medical writers and editors on editorial standards, document compilation, and publishing requirements

  • Train, mentor, and support junior medical editors and global medical writing team members

  • Support process improvement initiatives, including development or revision of editorial SOPs, workflows, and quality tools

  • Manage assigned projects in compliance with internal SOPs, client standards, timelines, and budgets

  • Support document compilation and publishing activities when required

Required Qualifications & Experience

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or a related scientific discipline

  • 6–9 years of professional experience in medical editing, quality control, or regulatory document editing within the pharmaceutical, biotech, or CRO industry

  • Proven experience editing regulatory documents such as CTDs, INDs, NDAs, BLAs, CSRs, protocols, IBs, and related submission documents

  • Strong working knowledge of global regulatory requirements and documentation standards

  • Expertise in AMA style, regulatory writing conventions, and editorial best practices

  • Demonstrated experience leading editorial teams and mentoring junior staff

  • Excellent attention to detail, time management, and stakeholder communication skills

Why Join Syneos Health

  • Opportunity to work on a majority of novel FDA-approved and EMA-authorized products

  • Structured career development, technical training, and leadership support

  • Inclusive and diverse work culture focused on employee well-being and growth

  • Exposure to global clinical programs and regulatory submissions

  • Competitive compensation and total rewards program

Additional Information

This job description is not exhaustive. Syneos Health reserves the right to modify duties and responsibilities as business needs evolve. Equivalent combinations of education, training, and experience may be considered. Employment is subject to applicable local labor laws and equal opportunity regulations.

Syneos Health is committed to providing reasonable accommodations for individuals with disabilities in accordance with applicable laws.