Location: India – Remote
Job ID: 25101317
Posted Date: August 29, 2025
Company: Syneos Health®
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With over 29,000 employees in 110 countries, we deliver tailored clinical, medical affairs, and commercial strategies to bring therapies to patients faster.
Our Impact:
Supported 94% of all novel FDA-approved drugs in the last 5 years
Contributed to 95% of EMA-authorized products
Participated in 200+ studies across 73,000+ sites and 675,000+ patients
As a Medical Writer I (CTD/CTT), you will contribute to the development, writing, editing, and submission of clinical and regulatory documents. This role emphasizes Clinical Trial Disclosure (CTD) and Clinical Trial Transparency (CTT) and involves close collaboration across cross-functional teams with moderate supervision.
Serve as a medical writer for clinical trial disclosure or transparency-related projects.
Compile, write, and edit medical documents including:
Clinical Study Protocols and Amendments
Clinical Study Reports (CSRs)
Patient Narratives
Investigator Brochures
Conduct protocol and results registration on trial registries (e.g., ClinicalTrials.gov).
Ensure consistency and compliance with CTD/CTT standards.
Review Statistical Analysis Plans and TFL (Tables, Figures, Listings) for clarity, accuracy, and consistency.
Provide editorial and structural feedback to improve output quality.
Work closely with internal departments:
Data Management
Biostatistics
Regulatory Affairs
Medical Affairs
Ensure deliverables are completed on time and within budget.
Maintain awareness of project scope and budget, communicating deviations to leadership.
Track and complete all administrative documentation in a timely manner.
Perform clinical literature reviews when needed.
Stay current on evolving regulatory guidelines and client expectations.
Continuously enhance writing and technical skills through self-learning and training.
| Requirement | Details |
|---|---|
| Experience | 6 months – 1 year in Clinical Trial Disclosure (CTD) or Clinical Trial Transparency (CTT) |
| Skills | - Protocol & results registration experience - Strong written & verbal communication - Excellent client interaction & management skills |
| Knowledge | - Familiarity with ICH-E3 guidelines - Understanding of regulatory writing principles and templates |
| Work Environment | Remote (India-based), with minimal travel required (up to 25%) |
People-first culture focused on career development and progression
Total Self Culture – authenticity and individuality are encouraged
Access to technical training, peer recognition programs, and wellness resources
Collaborative and inclusive global workforce
This job description outlines the typical scope of work and may be updated based on business needs.
Equivalent education, experience, or transferable skills will be considered.
Syneos Health complies with all Equal Opportunity and Disability legislation, including the Americans with Disabilities Act (ADA) and EU Equality Directives.
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“At Syneos Health, we believe diverse experiences drive innovation. Even if your experience doesn’t align perfectly with every qualification, we encourage you to apply.”
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Dรบn Laoghaire |Galway :
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China | Quarry Bay |Hubei :
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Hangzhou |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
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Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Paris | Lyon |Attica :
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Niลก |Singapore :
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Madrid |Sweden :
Sweden |Taipei :
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