Who We Are
Synteract®, a Syneos Health® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies.
With our mission of Bringing clinical trials to lifeTM , we provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.
Position Overview The Medical Writer is responsible for writing, editing and reviewing clinical study documents according to global regulatory guidance, templates, style guides and standard operating procedures (SOPs).
Clinical study documents may include but are not limited to study protocols and amendments, investigator brochures (IBs), informed consent forms (ICFs), annual safety reports, clinical study reports (CSRs), Integrated Summaries of Safety and Efficacy (ISS / ISE), and other sections of regulatory applications (IND, IDE, NDA, BLA and PMA submissions).
Other scientific documents (including but not limited to manuscripts, abstracts, posters) may also be developed. Specific tasks would include :
Advanced degrees (e.g., PhD, MS, MPH) preferred.