Medical Editor II – Clinical Pharmacology (CSR, IB & Protocol Editing)
Updated: December 22, 2025
Location: India – Remote
Job ID: 25104357
Job Type: Full-Time | Remote Opportunity
Company Overview
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success across clinical development, medical affairs, and commercialization. With operations in over 110 countries and a workforce of more than 29,000 professionals, Syneos Health partners with leading life sciences companies to deliver high-quality, patient-focused solutions across the product lifecycle.
Its innovative Clinical Development model places patients and sponsors at the center, emphasizing regulatory excellence, scientific integrity, and operational efficiency.
Role Overview
Syneos Health is seeking a Medical Editor II – Clinical Pharmacology to support the editing and quality review of complex regulatory and clinical documents, including Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and clinical trial Protocols.
This role is ideal for experienced medical editors with strong regulatory knowledge, exceptional attention to detail, and hands-on experience in editing clinical and regulatory submissions for global health authorities.
Key Responsibilities
Edit and quality-review clinical and regulatory documents to ensure accuracy, clarity, consistency, and compliance with FDA, EMA, and global regulatory guidelines.
Perform copyediting using AMA Manual of Style, sponsor-specific style guides, and internal medical writing standards.
Support editing of CSRs, IBs, protocols, and other clinical pharmacology documents.
Ensure written deliverables meet sponsor expectations and regulatory submission standards.
Represent the editorial function within medical writing teams, study teams, and cross-functional project groups.
Monitor assigned project timelines and budgets, escalating risks to lead medical writers or project managers when necessary.
Provide regular updates and feedback to lead medical writers on editorial progress.
Conduct detailed quality checks to maintain document integrity, scientific accuracy, and formatting consistency.
Manage assigned editorial projects in accordance with SOPs, client standards, and internal best practices, with minimal supervision.
Support document compilation and submission readiness activities as required.
Required Qualifications & Experience
Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, Clinical Pharmacology, or a related scientific discipline.
Minimum 4–6 years of experience in medical editing within a CRO, pharmaceutical, or biopharmaceutical environment.
Proven experience editing CSRs, Investigator’s Brochures, clinical protocols, and other regulatory documents.
Strong knowledge of FDA, EMA, ICH guidelines, and global regulatory submission requirements.
Excellent command of English grammar, syntax, and scientific writing standards.
Familiarity with AMA Manual of Style and sponsor-specific editorial guidelines.
Ability to manage multiple documents and timelines while maintaining high quality and accuracy.
Strong communication and collaboration skills for cross-functional team environments.
High attention to detail with the ability to work independently in a remote setting.
Why Join Syneos Health
Contribute to programs supporting 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years.
Work remotely on global, high-impact clinical development programs.
Access continuous professional development, technical training, and career progression opportunities.
Be part of a diverse, inclusive, and people-first global organization committed to quality and innovation.
Additional Information
Responsibilities outlined are not exhaustive and may evolve based on business requirements. Syneos Health is an equal opportunity employer and complies with all applicable employment and accessibility regulations. Reasonable accommodations are provided as required.
Apply Now
Apply through thepharmadaily.com to explore this opportunity in Medical Editing and Clinical Pharmacology.
Not ready to apply? Join the Talent Network to stay informed about future Medical Writing and Regulatory Editing roles worldwide.
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Niš |Bohemia :
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