Medical Editor Ii Clin Pharm (Editing Of Csr, Ib, Protocol)

Syneos Health

3-6 years

preferred by company

India Pune

10 Feb. 4, 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

Medical Editor II – Clinical Pharmacology (CSR, IB, Protocol Editing)

Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25104357
Employment Type: Full-Time

About the Company

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By translating clinical, medical affairs, and commercial insights into meaningful outcomes, Syneos Health supports sponsors in navigating today’s evolving healthcare and regulatory landscape.

With a patient-centric Clinical Development model, Syneos Health continuously simplifies and streamlines processes to enhance collaboration, efficiency, and delivery of high-quality therapies. Operating across more than 110 countries, the organization is driven by innovation, agility, and a shared mission to change lives.

Position Overview

The Medical Editor II – Clinical Pharmacology is responsible for ensuring the quality, accuracy, and regulatory compliance of clinical and medical documents, including Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and Protocols. This role supports medical writing teams by providing expert-level copyediting, quality control, and document management in alignment with global regulatory standards.

Key Responsibilities

Maintain in-depth knowledge of FDA, EMA, ICH, and other global regulatory guidelines and industry standards.
Perform comprehensive copyediting of clinical documents, ensuring accuracy in grammar, punctuation, terminology, formatting, and style in accordance with the AMA Manual of Style and client-specific guidelines.
Conduct detailed quality reviews to ensure consistency, data integrity, and regulatory compliance across medical writing deliverables.
Collaborate with medical writers, project managers, and cross-functional teams as part of study and project teams.
Monitor project timelines and budgets; proactively communicate risks to deliverables to lead medical writers or project leadership.
Manage assigned editorial tasks in compliance with medical writing SOPs, client standards, and internal quality checklists.
Provide structured feedback to lead medical writers on editorial progress and document readiness.
Support compilation and finalization of medical writing deliverables, as required.

Required Qualifications and Experience

Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, or a related discipline; advanced degree preferred.
3–6 years of relevant experience in medical editing, medical writing support, or clinical documentation within a CRO, pharmaceutical, or biotechnology environment.
Proven experience editing CSRs, IBs, protocols, and other regulatory submission documents.
Strong working knowledge of global regulatory requirements and medical writing standards.
Proficiency in AMA Manual of Style and document quality control best practices.
Ability to manage multiple deliverables independently while meeting strict timelines and quality expectations.
Strong attention to detail, communication skills, and ability to collaborate in cross-functional teams.

Why Join Syneos Health

Comprehensive career development and progression opportunities.
Access to technical, therapeutic, and professional training programs.
Supportive leadership and collaborative team culture.
Commitment to diversity, equity, inclusion, and the “Total Self” workplace culture.
Opportunity to contribute to studies supporting the majority of recently approved FDA and EMA therapies.

Additional Information

This job description outlines the primary responsibilities of the role but is not exhaustive. Syneos Health reserves the right to assign additional duties as required. Equivalent combinations of education, skills, and experience will be considered. Employment terms are governed by applicable local laws and regulations, including equal employment and disability accommodation standards.

Role Summary

The Medical Editor II – Clinical Pharmacology ensures the quality, compliance, and consistency of clinical and regulatory documents through expert copyediting, quality review, and document management. The role supports high-quality medical writing deliverables that meet customer expectations and global regulatory submission standards with minimal supervision.

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Medical Editor Ii Clin Pharm (Editing Of Csr, Ib, Protocol)

Job Description

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