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Medical Writer Ii (Clinical Trial Transparency)

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

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Meta Title

Medical Writer II – Clinical Trial Transparency | Remote India

 

Medical Writer II – Clinical Trial Transparency (Remote, India)

Job Summary

Syneos Health is seeking a highly skilled Medical Writer II with expertise in clinical trial transparency to join its global medical writing team. This fully remote role offers an excellent opportunity to work with leading pharmaceutical clients, authoring a wide range of regulatory documents including clinical study protocols, CSRs, and investigator brochures. Candidates should bring strong writing experience, a solid understanding of ICH-E3 guidelines, and an eye for scientific detail and clarity.


Key Responsibilities

  • Write, compile, and edit high-quality regulatory documents (protocols, CSRs, narratives, IBs).

  • Perform peer reviews and respond to feedback to ensure content accuracy and consistency.

  • Conduct literature reviews and adhere to regulatory guidelines and SOPs.

  • Mentor junior writers and contribute to cross-functional project teams.

  • Work with data management, biostatistics, and medical affairs departments.

  • Manage timelines and deliverables across multiple projects.

  • Stay updated with evolving regulatory documentation practices.


Required Skills & Qualifications

  • Bachelor's degree in Life Sciences or English/Communications with relevant scientific knowledge.

  • 3+ years of experience in medical writing (clinical research/regulatory documents).

  • Familiarity with ICH E3, FDA guidelines, and AMA style.

  • Strong command of English grammar and document formatting.

  • Proficiency with MS Word, Excel, PowerPoint, and document review tools.

  • Understanding of clinical research processes and ability to interpret scientific data.


Perks & Benefits

  • 100% remote work flexibility across India.

  • Career growth with a global leader in clinical and regulatory solutions.

  • Supportive culture with continuous professional development.

  • Competitive salary and performance-driven incentives.

  • Access to internal training and learning platforms.


Company Description

Syneos Health is a fully integrated biopharmaceutical solutions company, providing clinical development and commercialization services to pharma, biotech, and medical device companies. The company partners with 94% of all new FDA-approved drugs and is a leader in transforming clinical research worldwide.


Work Mode

Remote – India


Call-to-Action

Ready to elevate your career in medical writing? Join Syneos Health and contribute to meaningful clinical research across the globe.
[Apply Now] and make an impact in clinical trial transparency.