Medical Writer I (Ctt)

Syneos Health

1+ years

Not Disclosed

Pune

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..

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Medical Writer I (Ctt)

Job Description

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