Location: Remote (India)
Job ID: 25101317
Updated: August 29, 2025
Are you a skilled Medical Writer with experience in Clinical Trial Disclosure (CTD) and Clinical Trial Transparency (CTT)? Syneos Health, a leading global biopharmaceutical solutions organization, is actively hiring for a remote Medical Writer I position based in India. This is an excellent opportunity to advance your career with an industry pioneer dedicated to accelerating patient success. If you have 6 months to 1 year of relevant experience, we encourage you to read the full job description and apply today.
About Syneos Health
Syneos Health® is a premier fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities. With a powerful Clinical Development model that places the customer and patient at the center of everything, Syneos Health is committed to simplifying and streamlining processes.
- Global Reach: 29,000 employees across 110 countries.
- Industry Impact: Over the past 5 years, they have worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products.
- Culture: They foster a ‘Total Self’ culture – a global environment where you can authentically be yourself. They are passionate about developing their people through career progression, supportive management, and comprehensive training programs.
Job Description: Medical Writer I (CTD/CTT)
The Medical Writer I will serve as a key contributor on clinical study and regulatory project teams. This role involves compiling, writing, and editing critical clinical documents with moderate supervision.
Key Responsibilities:
- Develop and support a variety of clinical documentation, including:
- Clinical study protocols and amendments.
- Clinical study reports (CSRs).
- Patient narratives.
- Investigator brochures (IBs).
- Gain experience in Clinical Trial Disclosure (CTD) and Clinical Trial Transparency (CTT) activities, including protocol registration and results registration on public platforms.
- Review statistical analysis plans (SAPs) and table/figure/listing (TFL) specifications for content, grammar, and consistency.
- Interact closely with cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs.
- Ensure all writing deliverables adhere to ICH-E3 guidelines, client standards, and company SOPs.
- Manage assigned projects to ensure they are completed on-time and on-budget.
- Perform online clinical literature searches as needed.
Qualifications and Experience Required:
- Experience: A minimum of 6 months to 1 year of experience in clinical trial disclosure (CTT/CTD), protocol registration, or result registration is essential.
- Skills: Excellent communication and client management skills are a must.
- Knowledge: Familiarity with regulatory standards (e.g., ICH-E3) and the clinical development process.
- Attributes: Detail-oriented, agile, and driven to accelerate the delivery of therapies.
