Medical Writing II – CSR Narrative & QC Review (Remote, India)
Job Summary:
Syneos Health is hiring a Medical Writing II professional with strong expertise in CSR Narrative writing and quality control (QC) review. This fully remote role offers the opportunity to contribute to global clinical documentation across multiple therapeutic areas. Ideal for medical writers with 3+ years of relevant experience, this position allows you to work in a collaborative, process-driven team while developing regulatory-standard documents in line with ICH-E3 and FDA guidance.
Key Responsibilities:
Independently write and review CSR Narratives and other clinical documents
Compile, edit, and finalize deliverables like clinical study reports, protocols, IBs, and annual reports
Serve as a peer reviewer for internal writing teams and ensure scientific accuracy and regulatory alignment
Review statistical analysis plans, TFLs, and ensure format consistency and grammar compliance
Follow AMA style guide, company SOPs, and client templates during all stages of writing
Guide and mentor junior medical writers as needed
Perform clinical literature searches to support content development
Track document timelines, manage project hours, and ensure delivery within budget
Contribute to ongoing professional development and stay updated on regulatory medical writing trends
May require occasional travel (less than 25%)
Required Skills & Qualifications:
Minimum 3 years of medical writing experience, with at least 3 years in CSR Narrative authoring and review
Bachelor's degree in Life Sciences, Clinical Research, English, Journalism, or related fields
Strong knowledge of ICH, FDA regulations, and AMA formatting standards
Excellent command of English grammar, clinical data interpretation, and content accuracy
Experience using Microsoft Word, Excel, PowerPoint, and online medical literature databases
Strong interpersonal, time management, and peer collaboration skills
Ability to manage multiple projects with minimal supervision
Perks & Benefits:
100% Remote work flexibility across India
Competitive compensation aligned with experience
Opportunities for global project exposure and cross-functional collaboration
Inclusive work culture promoting Total Self and well-being
Technical, therapeutic, and leadership training programs
Career progression within a top-tier global biopharmaceutical services organization
Company Description:
Syneos Health is a globally recognized clinical research and biopharmaceutical solutions company supporting over 95% of EMA and FDA-authorized products. With over 29,000 employees in 110+ countries, we help advance clinical, regulatory, and commercial success across the life sciences industry.
Work Mode: Remote (India)
Call to Action:
Are you an experienced CSR narrative writer looking to grow in a global clinical writing team? Apply now for the Medical Writing II – CSR Narrative role at Syneos Health and contribute to impactful, patient-focused medical documentation.
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