Medical Writer I (CTD/CTT)
Location: IND-Gurugram-Hybrid
Updated: August 29, 2025
Job ID: 25101317
Company Overview
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by transforming clinical, medical affairs, and commercial insights into outcomes.
Patient- and customer-centric Clinical Development model
Agile, collaborative, and innovative teams
29,000 employees across 110 countries
Global Impact:
94% of novel FDA-approved drugs and 95% of EMA-authorized products in last 5 years
200+ studies across 73,000 sites and 675,000+ trial patients
Learn more: www.syneoshealth.com
Why Syneos Health
Career Development: Training, mentorship, and progression opportunities
Inclusive Culture: Total Self culture fostering authenticity and belonging
Collaboration: Cross-functional teamwork to achieve customer goals
Role Summary
The Medical Writer I (CTD/CTT) supports clinical and regulatory writing projects, assisting in preparation, review, and coordination of deliverables under moderate supervision.
Focused on Clinical Trial Disclosure (CTD/CTT) and protocol/result registration
Assists senior writers in producing high-quality clinical and regulatory documents
Core Responsibilities
Medical Writing & Document Support
Compile, write, and edit documents, including:
Clinical study protocols and amendments
Clinical study reports (CSRs)
Patient narratives
Investigator brochures (IBs)
Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency
Perform online clinical literature searches, ensuring copyright compliance
Collaboration & Client Interaction
Interact with department heads and staff in:
Data management, Biostatistics, Regulatory Affairs, Medical Affairs
Communicate effectively with clients and internal teams
Compliance & Standards
Adhere to regulatory guidelines, including ICH E3, company SOPs, client standards, and approved templates
Ensure deliverables are completed on time and within budget
Maintain professional development to keep pace with evolving regulations and client expectations
Administrative & Miscellaneous
Complete administrative tasks within required timeframes
Minimal travel may be required (<25%)
Perform other work-related duties as assigned
Qualifications & Experience
6 months – 1 year of experience in Clinical Trial Disclosure (CTD/CTT)
Experience with protocol registration and result registration
Strong communication and client management skills
Key Skills
Competence in medical writing for clinical and regulatory documents
Understanding of statistical outputs and clinical trial data
Familiarity with ICH E3 and regulatory standards
Strong attention to detail and organizational skills
Ability to work collaboratively under moderate supervision
Additional Information
Tasks and responsibilities may be adjusted at company discretion
Equivalent skills and experience will be considered
Compliance with employment legislation and ADA requirements
How to Apply
Apply via Syneos Health careers portal
Join the Talent Network to stay connected with future opportunities
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