Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With a focus on clinical, medical affairs, and commercial insights, Syneos Health translates innovation into real-world outcomes.
Operating in 110 countries with 29,000 employees, Syneos Health is committed to simplifying clinical development and bringing patients and customers to the center of everything they do. Their agile and driven approach ensures the timely delivery of life-changing therapies.
Why Join Syneos Health?
- Career Growth: Opportunities for professional development and progression.
- Inclusive Culture: A “Total Self” culture that encourages authenticity and diversity.
- Global Impact: Work on groundbreaking clinical trials with leading biopharma companies.
Job Description: Medical Writer I
Key Responsibilities:
- Write and edit medical writing deliverables, including:
- Clinical study protocols & amendments
- Clinical study reports (CSRs)
- Patient narratives
- Investigator brochures (IBs)
- Review statistical analysis plans (SAPs) and table/figure/listing (TFL) specifications for consistency and accuracy.
- Collaborate with cross-functional teams (data management, biostatistics, regulatory affairs).
- Ensure compliance with ICH-E3 guidelines, SOPs, and client-specific templates.
- Conduct clinical literature searches and stay updated with regulatory standards.
- Manage budgeted hours and communicate project updates to leadership.
- Perform quality checks (QC) on documents.
- Support Clinical Trial Disclosure (e.g., ClinicalTrials.gov, EUCTR, FDA postings).
Preferred Experience:
- Clinical Trial Disclosure (CT.gov, EUCTR)
- Regulatory Medical Writing (CTD documents)
- Pharmacovigilance & Safety Narrative Writing
Qualifications:
- Postgraduate in Life Sciences (M.Pharm, PharmD preferred)
- Experience in regulatory writing, clinical documentation, or pharmacovigilance
- Familiarity with FDA, EMA, and ICH guidelines
- Strong scientific writing & editing skills
