Senior Medical Editor – Regulatory Documents Quality Control (QC)
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25104158
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a globally integrated biopharmaceutical solutions organization dedicated to accelerating the delivery of innovative therapies. By combining expertise across clinical development, medical affairs, and commercialization, Syneos Health partners with sponsors to address complex regulatory and market challenges worldwide.
With a presence in more than 110 countries, Syneos Health is recognized for its patient-centric approach, scientific excellence, and commitment to quality and compliance across the drug development lifecycle.
Role Overview
The Senior Medical Editor – Regulatory Documents QC is responsible for ensuring the editorial quality, data integrity, and regulatory compliance of clinical and regulatory documents. This role provides advanced editorial oversight for regulatory deliverables and supports cross-functional teams to ensure submissions meet global regulatory standards and sponsor expectations.
The position requires strong expertise in regulatory document editing, quality control processes, and leadership within medical writing and editorial teams.
Key Responsibilities
Regulatory Quality and Editorial Oversight
Maintain in-depth knowledge of FDA, EMA, and other global regulatory guidelines and industry standards to ensure regulatory documents meet or exceed sponsor and health authority requirements.
Perform detailed copyediting of regulatory documents, applying correct grammar, punctuation, spelling, and formatting in accordance with the AMA Manual of Style, internal checklists, and client-specific editorial guidelines.
Conduct thorough data integrity and quality control reviews to ensure accuracy, consistency, and alignment with source data and regulatory expectations.
Project Leadership and Cross-Functional Collaboration
Represent the medical editing function within Medical Writing teams, study teams, and cross-departmental project teams.
Serve as project lead for complex or large regulatory deliverables, coordinating editorial activities, timelines, and internal review processes.
Monitor project timelines and budgets, proactively communicating risks and status updates to Lead Medical Writers, Project Managers, and leadership.
Technical Expertise and Mentorship
Provide advanced technical and editorial guidance to medical writers, editors, and study teams on regulatory document standards, data integrity review, compilation, and publishing.
Deliver training and mentorship to medical editing staff and contribute to capability building within the global Medical Writing organization.
Advise teams on best practices related to regulatory document preparation, quality control, and submission readiness.
Process Improvement and Document Management
Contribute to the development and continuous improvement of editorial workflows, tools, policies, and standard operating procedures.
Manage assigned projects in accordance with internal SOPs and client standards, ensuring on-time and on-budget delivery.
Support document compilation and publishing activities for regulatory submissions, as required.
Required Qualifications and Experience
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline; advanced degree preferred.
5–8 years of professional experience in medical editing, regulatory document quality control, or medical writing, preferably within a CRO, pharmaceutical, or biotechnology environment.
Hands-on experience editing and QC-reviewing regulatory documents such as clinical study reports, protocols, investigator brochures, and submission-ready documents.
Strong understanding of FDA, EMA, and international regulatory guidelines and documentation standards.
Expert-level proficiency in English grammar and scientific language, with strong familiarity with the AMA Manual of Style.
Proven ability to lead editorial activities, manage multiple projects, and mentor junior editorial staff.
Why Join Syneos Health
Work on regulatory submissions supporting a majority of recently approved FDA and EMA products.
Access structured career development, leadership training, and therapeutic-area learning opportunities.
Collaborate with global teams on high-impact regulatory and clinical development programs.
Be part of an inclusive, people-focused organization committed to professional growth and innovation.
Additional Information
This job description outlines the primary responsibilities of the role but is not exhaustive. Syneos Health may assign additional duties as business needs evolve. Equivalent education, skills, and experience may be considered. All employment practices comply with applicable local and international employment laws, including equal opportunity and reasonable accommodation requirements.
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