Location: Gurugram, India (Hybrid)
Job ID: 25101317
Updated: August 29, 2025
Company: Syneos Health®
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization that accelerates customer success by transforming clinical, medical affairs, and commercial insights into real-world outcomes. With over 29,000 employees across 110 countries, we are united in our commitment to making a meaningful difference in patients' lives.
People-Centric Culture: Career development, progression support, peer recognition, and total rewards.
Total Self Culture: Be your authentic self in a diverse and inclusive workplace.
Global Impact: We've supported 94% of all novel FDA-approved drugs in the last 5 years and managed over 200 studies across 675,000+ patients.
Work here matters everywhere.
As a Medical Writer I (CTD/CTT), you will support clinical study and regulatory project teams by writing, editing, and coordinating clinical and regulatory documents. This role involves collaboration across departments with moderate supervision.
Serve as a medical writer on clinical trial disclosure (CTD) or clinical trial transparency (CTT) projects.
Compile, write, and edit various medical writing deliverables such as:
Clinical Study Protocols & Amendments
Clinical Study Reports
Patient Narratives
Investigator Brochures
Ensure adherence to:
ICH-E3 guidelines
Company SOPs
Client-specific standards and templates
Experience in protocol registration and results posting on disclosure platforms (e.g., ClinicalTrials.gov).
Perform online literature reviews as applicable.
Interact with Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs.
Review Statistical Analysis Plans and TFL specifications for clarity, grammar, format, and consistency.
Manage time and deliverables within budgeted hours.
Communicate any scope or time changes to medical writing leadership.
Complete all required administrative tasks on time.
Participate in ongoing professional development.
Perform additional tasks as assigned.
Travel may be required (up to 25%).
Experience: Minimum 6 months to 1 year in Clinical Trial Disclosure (CTD) or Clinical Trial Transparency (CTT).
Technical Expertise:
Protocol and results registration experience
Familiarity with regulatory documents and guidelines
Soft Skills:
Excellent communication and client management
Strong attention to detail and organizational skills
This job description is not exhaustive. Tasks and responsibilities may change at the company's discretion.
Equivalent experience, education, and transferable skills will be considered.
Syneos Health is an Equal Opportunity Employer and complies with ADA requirements.
Apply Now
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