Syneos Health® is a leading global biopharmaceutical solutions organization accelerating customer success through integrated clinical, medical affairs, and commercial insights. With 29,000+ employees across 110 countries, Syneos Health is known for its patient-centric approach and innovative clinical development models. Over the past 5 years, they’ve partnered with:
- 94% of all Novel FDA Approved Drugs
- 95% of EMA Authorized Products
- 675,000+ Trial Patients across 73,000 sites
Their Total Self culture fosters diversity, inclusion, and career growth, making Syneos Health a top workplace for medical writing professionals.
Job Description: Medical Writer II (CSR Narrative & QC Review)
Key Responsibilities
- Author and review Clinical Study Report (CSR) Narratives independently.
- Develop clinical study protocols, investigator brochures, and patient narratives.
- Ensure compliance with ICH-E3, FDA, and AMA style guidelines.
- Collaborate with biostatistics, data management, and regulatory teams.
- Perform QC reviews and mentor junior medical writers.
- Adhere to budget timelines and regulatory standards.
Qualifications & Skills
- Bachelor’s degree in Science/English/Communications (preferred).
- 3+ years of medical writing experience, specifically in CSR Narratives.
- Strong knowledge of clinical research, ICH-GCP, and FDA guidelines.
- Proficiency in Microsoft Word, Excel, and literature searches.
- Excellent grammar, proofreading, and interpersonal skills.
Why Join Syneos Health?
✅ Career Growth: Training, mentorship, and leadership opportunities.
✅ Inclusive Culture: Emphasis on diversity, authenticity, and work-life balance.
✅ Impactful Work: Contribute to life-changing therapies for global patients.
