Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With a workforce of 29,000 employees across 110 countries, Syneos Health combines clinical, medical affairs, and commercial expertise to address modern market challenges.
The company fosters a “Total Self” culture, encouraging employees to bring their authentic selves to work while promoting diversity, inclusion, and career growth. Syneos Health has contributed to 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products over the past five years, working across 73,000+ sites and 675,000+ trial patients.
Job Description: Medical Writer II
Syneos Health is seeking an experienced Medical Writer II to join their team in India. This remote role involves developing high-quality clinical and regulatory documents while mentoring junior writers.
Key Responsibilities:
- Write, edit, and review medical writing deliverables, including:
- Clinical study protocols & amendments
- Clinical study reports (CSRs)
- Patient narratives
- Investigator brochures (IBs)
- Annual reports
- Review statistical analysis plans (SAPs) and table/figure/listing (TFL) specifications for accuracy and consistency.
- Collaborate with cross-functional teams (data management, biostatistics, regulatory affairs).
- Ensure compliance with ICH-E3, FDA, and AMA style guidelines.
- Peer review documents for clarity, scientific accuracy, and formatting.
- Stay updated on regulatory guidelines and industry best practices.
- Manage project timelines and budgets efficiently.
Qualifications & Skills:
- Education: Postgraduate (Master’s/MPHARM) or Bachelor’s degree in Life Sciences/Pharmacy/Medicine.
- Experience: Minimum 1+ years in drafting and reviewing clinical narratives (mandatory).
- Regulatory Knowledge: Familiarity with ICH, FDA, and EMA guidelines.
- Technical Skills: Proficiency in Microsoft Word, Excel, PowerPoint, and literature search tools.
- Soft Skills: Strong attention to detail, leadership, and teamwork abilities.
Why Join Syneos Health?
- Career Growth: Continuous learning and professional development opportunities.
- Flexible Work Model: Remote work options with minimal travel (<25%).
- Inclusive Culture: Emphasis on diversity, collaboration, and employee well-being.
