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Medical Writer I (Ctt)

1+ years
Not Disclosed
10 July 3, 2025
Job Description
Job Type: Full Time 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 I – Clinical Trial Transparency (CTT) | Pune | Syneos Health

Job Summary:
Syneos Health is hiring a Medical Writer I – Clinical Trial Transparency (CTT) in Pune. This role is ideal for candidates with minimum 1 year of experience in clinical trial disclosure and results registration. You’ll collaborate with clinical and regulatory teams to compile and edit high-quality content including study protocols, CSRs, and patient narratives. This is a great opportunity to work in a global biopharma organization driving innovation and regulatory excellence.


Key Responsibilities:

  • Prepare, compile, and edit regulatory and clinical documents such as:

    • Clinical study protocols and amendments

    • Clinical study reports (CSRs)

    • Investigator brochures

    • Patient narratives

  • Register study protocols and post results for regulatory compliance

  • Collaborate with cross-functional teams (Data Management, Biostatistics, Regulatory, Medical Affairs)

  • Review SAPs, tables, and listings for clarity and consistency

  • Conduct literature searches as needed

  • Ensure adherence to ICH-E3 guidelines, SOPs, and client standards

  • Track project progress within allocated budget and timelines

  • Maintain audit-readiness and contribute to quality improvement


Required Skills & Qualifications:

  • Minimum 1 year of experience in clinical trial disclosure (CTT) or related documentation

  • Experience in protocol registration and results posting

  • Familiarity with ICH-GCP, regulatory guidelines, and medical writing best practices

  • Strong written and verbal communication skills

  • Proficiency in MS Office and document management tools

  • Bachelor’s or advanced degree in life sciences, pharmacy, or medical writing-related field


Perks & Benefits:

  • Global exposure to high-impact biopharma projects

  • Career development programs and learning opportunities

  • Inclusive “Total Self” workplace culture

  • Competitive salary and performance incentives

  • Comprehensive health benefits

  • Flexible work options and professional recognition programs


Company Description:

Syneos Health is a global, fully integrated biopharmaceutical solutions organization with over 29,000 employees in 110 countries. The company supports clinical development, medical affairs, and commercialization services for life-changing therapies. With a track record of partnering in over 94% of all FDA-approved novel drugs, Syneos Health leads in innovation and real-world impact across clinical research and regulatory writing.


Work Mode: On-site (Pune, India)


Call-to-Action:

If you're ready to contribute to impactful regulatory science and work with a world-class team, apply now for the Medical Writer I (CTT) role at Syneos Health in Pune. Be part of a purpose-driven organization that puts patients and innovation first..