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Medical Writing Ii (Csr Narrative, Qc Review)

3+ years
Not Disclosed
10 July 30, 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 Writer II – CSR Narrative (Remote, India)

Location: Remote (India)
Company: Syneos Health
Experience Required: Minimum 3 years in medical writing, with at least 3 years of CSR Narrative experience
Job Type: Full-time
Compensation Range: Not specified


Job Summary

Join Syneos Health, a global biopharmaceutical solutions leader, as a Medical Writer II focusing on CSR Narratives. In this fully remote role, you will independently author and quality check clinical study report (CSR) narratives, mentor junior writers, and collaborate across functions. This is a dynamic opportunity for experienced writers to contribute to high-impact regulatory documents and work within international clinical development projects.


Key Responsibilities

  • Independently author and QC CSR Narratives in alignment with regulatory standards

  • Mentor junior medical writers and review peer work

  • Write, compile, and edit a variety of clinical documents including protocols, investigator brochures, and study reports

  • Review statistical analysis plans and TFL specs for content, grammar, format, and consistency

  • Liaise with teams across data management, biostatistics, regulatory affairs, and clinical operations

  • Conduct online literature searches and ensure adherence to ICH-E3, FDA, and internal SOPs

  • Monitor project hours and adhere to timeline and budget specifications


Required Skills & Qualifications

  • Minimum 3 years of professional medical writing experience

  • Minimum 3 years of CSR narrative writing experience

  • Bachelor's degree in Life Sciences, English, Communications, or a related field

  • Excellent command of English grammar and regulatory guidelines (ICH, FDA)

  • Familiarity with AMA style, Microsoft Office tools, and principles of clinical research

  • Strong proofreading, communication, and leadership skills

  • Ability to interpret and present complex clinical data clearly and concisely


Perks & Benefits

  • Fully remote work setup with flexible environment

  • Career progression with technical and therapeutic area training

  • Supportive leadership and peer recognition programs

  • Opportunities to work with top global pharmaceutical sponsors

  • Inclusive and diverse work culture with Total Self wellness initiatives

  • Minimal travel (<25%) may be required


About Syneos Health

Syneos Health is a global, fully integrated biopharmaceutical solutions company. With operations in over 110 countries and 29,000+ employees, the company partners with biotech and pharma leaders to accelerate clinical development. Known for working on 94% of all FDA-approved novel drugs in the past five years, Syneos is a powerhouse in clinical research, medical affairs, and commercialization services.


Work Mode

Remote (India-based candidates only)


Apply Now

Are you an experienced medical writer looking to make a difference in drug development? Join Syneos Health and help bring life-changing therapies to market.
Apply today and be part of a team where your work matters everywhere.