Syneos Health, a global leader in biopharmaceutical solutions, is hiring Medical Writer I (CTD/CTT) and Medical Writer II positions in India. These roles offer remote and hybrid (Gurugram) options, giving professionals in medical writing, clinical trial disclosure, and regulatory documentation a chance to grow with a top multinational organization.
With over 29,000 employees across 110 countries, Syneos Health is known for shaping healthcare innovation. If you are passionate about clinical research writing, disclosure management, CTD/CTIS, and client collaboration, this is the perfect opportunity to accelerate your career.
🔹 Job Responsibilities
Medical Writer I (CTD/CTT) – Key Duties
- Minimum 6 months – 1 year experience in Clinical Trial Disclosure/CTT
- Strong knowledge of protocol registration and result disclosure
- Draft and edit clinical documents: protocols, amendments, study reports, patient narratives, investigator brochures
- Perform quality checks for statistical analysis plans and study outputs
- Collaborate with biostatistics, data management, regulatory, and medical affairs teams
- Adhere to ICH-E3 guidelines, regulatory standards, SOPs, and client templates
Medical Writer II – Key Duties
- 1–3 years of experience in disclosure and clinical registries (CT.gov, CTIS, EUDRACT)
- Lead clinical trial disclosure and redaction activities
- Develop advanced documents: annual reports, informed consents, plain language summaries, PSURs, INDs, NDA submissions, abstracts, and manuscripts
- Act as peer reviewer and mentor junior writers
- Ensure compliance with FDA, ICH, and good publication practices
- Perform literature searches and ensure copyright compliance
🔹 Qualifications
- Medical Writer I: Life science degree with clinical trial disclosure/CTT experience
- Medical Writer II: Bachelor’s or higher degree in life sciences; strong experience in disclosure and regulatory writing
- Strong command of medical terminology, clinical data interpretation, and AMA Manual of Style
- Excellent communication, client management, and collaboration skills
- Proficiency in MS Office and documentation tools
🔹 Why Join Syneos Health?
- Work with a leading biopharmaceutical solutions company
- Remote flexibility with hybrid option in Gurugram
- Structured career development and training programs
- Competitive salary and total rewards program
- Global exposure to FDA, EMA, and CTD submissions
🔹 Application Process
Application Link for Medical Writer I (CTD/CTT)
Application Link for Medical Writer II
