Updated: August 26, 2022
Location: Raleigh, NC, United States
Job ID: 139237
This opportunity is with Syneos Health Consulting. Your primary focus will be to conduct External GCP Audits. You will work with some of the industries sharpest minds, and will enjoy flexibility to conduct your professional Pharmaceutical and Biotech Clinical Audits as the lead and primary auditor. To be successful in this role, you will need to have extensive experience as the lead or primary auditor conducting external sponsor audits, deep understanding of CRO auditing and excellent communication skills.
You will be joining an industry-leading consulting firm, Syneos Health, specializing in the biopharmaceutical industry providing services across a comprehensive range of key Practice Areas including commercial strategy and planning, medical affairs, risk and program management and pricing and market access. You’ll join a team with industry focus, depth of functional expertise, and strong scientific and market knowledge that is uniquely positioned to tackle highly complex business and market challenges to develop successful commercial strategies for our clients.
In this role, you will schedule, conduct and document assigned audits of projects in accordance with approved procedures, schedules and formats. Specific audit areas will include, but are not limited to: investigator sites, trial master and project management files, data management activities and files, safety reporting, final study reports, and vendors. More specifically:
Please note - This is a remote-based position (any US location) that will require up to 75% travel.
Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:
I understand that if I am made an offer of employment, it will be conditioned on my demonstration I am fully vaccinated OR I plan to initiate vaccination by my start date AND be fully vaccinated within 4 weeks of start date against the COVID-19 virus.
IMPORTANT: I understand that if the role for which I am applying requires extensive in-person contact with colleagues, health care providers, clients and other medical professionals who have stringent vaccination requirements that all Syneos Health employees with whom they partner be fully vaccinated and will not accept or consider any exemptions. I understand I can request an exemption from Syneos Health’s vaccination requirement based on a qualifying medical condition or sincerely-held religious belief. However, in the event that I successfully obtain an exemption, I understand that it is highly unlikely that I will be able to adequately perform the essential functions of this position without imposing an undue hardship on Syneos Health due to the clients’ demands.
#CRO #Clinical #LifeScience #pharmaceuticals #ASQ #SQA
Discover what our 24,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: