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 transforms innovative ideas into real-world outcomes.
Why Join Syneos Health?
- Career Growth: Opportunities for professional development and progression.
- Inclusive Culture: A Total Self culture where you can authentically be yourself.
- Global Impact: Work with a team of 29,000+ employees across 110 countries.
- Industry Leader: Involved in 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products over the past 5 years.
Medical Writer I – Key Responsibilities
As a Medical Writer I at Syneos Health, you will:
✔ Compile, write, and edit medical writing deliverables under moderate supervision.
✔ Develop key documents, including:
- Clinical study protocols & amendments
- Clinical study reports
- Patient narratives
- Investigator brochures
✔ Review statistical analysis plans (SAPs) and ensure compliance with ICH-E3 guidelines.
✔ Collaborate with data management, biostatistics, and regulatory affairs teams.
✔ Conduct clinical literature searches and adhere to regulatory standards.
✔ Ensure projects are completed on time and within budget.
Qualifications & Experience
- Education: Postgraduate in Life Sciences (Preferred: M.Pharm, PharmD).
- Experience:
- Clinical Trial Disclosure
- Regulatory Medical Writing
- Pharmacovigilance (Safety Narrative Writing)
- Preferred Skills:
- Drafting CTD (Common Technical Document) submissions
- Experience with US FDA, ClinicalTrials.gov (ct.gov), EUCTR postings
