Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With 29,000+ employees across 110 countries, Syneos Health combines clinical, medical affairs, and commercial expertise to deliver impactful healthcare solutions.
Why Syneos Health?
- Career Growth: Professional development and progression opportunities.
- Inclusive Culture: A Total Self culture that values diversity and authenticity.
- Global Impact: Work on groundbreaking clinical trials and novel FDA-approved drugs.
Job Description: Medical Writer II (Clinical Trial Transparency)
Key Responsibilities:
- Mentor junior writers and ensure high-quality medical writing deliverables.
- Develop, write, and edit clinical documents, including:
- Clinical study protocols & amendments
- Clinical study reports (CSRs)
- Patient narratives
- Investigator brochures (IBs)
- Annual reports
- Review statistical analysis plans (SAPs) and ensure compliance with ICH-E3, FDA, and AMA guidelines.
- Collaborate cross-functionally with biostatistics, regulatory affairs, and medical affairs teams.
- Ensure adherence to budgets and timelines while maintaining document accuracy.
- Stay updated on regulatory guidelines and industry best practices.
Qualifications & Skills:
- Bachelor’s degree in Science (preferred) or Arts (Social Sciences/English/Communications).
- Proven experience in medical writing within clinical trials.
- Strong knowledge of FDA/ICH guidelines and AMA style.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Excellent communication, leadership, and proofreading skills.
Benefits & Perks:
- Competitive salary & benefits
- Flexible & inclusive work environment
- Continuous learning & development programs
- Global career opportunities
How to Apply
Ready to join Syneos Health? Apply now!
- Job ID: 25002559
- Location: Pune, Maharashtra, India
