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Medical Writing Ii (Csr Narrative, Qc Review)

3+ years
Not Disclosed
10 July 9, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 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.