Syneos Health is a leading global contract research organization (CRO) that collaborates with biopharmaceutical companies to accelerate drug development. With a strong presence in clinical research, regulatory affairs, and medical communications, Syneos Health offers dynamic career opportunities for professionals in the life sciences sector.
Job Description
Role & Responsibilities
As a Medical Writer at Syneos Health, you will:
- Compile, write, and edit medical writing deliverables under moderate supervision.
- Develop clinical study documents, including:
- Clinical study protocols & amendments
- Clinical study reports (CSRs)
- Patient narratives
- Investigator brochures (IBs)
- Review statistical analysis plans (SAPs) for accuracy and consistency.
- Collaborate with cross-functional teams (data management, biostatistics, regulatory affairs).
- Ensure compliance with ICH-E3 guidelines, SOPs, and client-specific templates.
- Conduct literature searches to support document development.
- Adhere to project budgets and timelines.
Preferred Candidate Profile
- Education: M.Pharm, PharmD, or any Life Science postgraduate.
- Experience:
- Clinical Trial Disclosure (CT.gov, EUCTR, FDA postings)
- Regulatory Medical Writing (Protocols, CSRs, IBs)
- Pharmacovigilance & Safety Narrative Writing
- Skills:
- Strong medical writing & editing abilities
- Knowledge of ICH-GCP & regulatory guidelines
- Experience with ClinicalTrials.gov (CT.gov) & EUCTR postings
How to Apply
