MMS is seeking a Senior Quality and Compliance Specialist to maintain a strong understanding of regulations and guidance as they pertain to compliance, and to support clients with development or refinement of Quality Management Processes or Systems. The ideal candidate will have expertise within CROs, scientific and clinical data/terminology, and the drug development process, and will be proficient in MS Office applications.
Requirements
- College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years' experience in GCP regulated industry if not a college graduate
- Minimum of 5 to 7 years' experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor)
- Expertise within CROs, scientific and clinical data/terminology, and the drug development process
- Experience with project oversight including but not limited to; document management, vendor qualifications, training management
- Proficiency with MS Office applications
- Hands-on experience with clinical trial and pharmaceutical development preferred
- Good communication skills and willingness to work with others to clearly understand needs and solve problems
- Excellent problem-solving skills
- Good organizational and communication skills
- Proficient with applicable regulatory requirements
- Must have strong technical writing skills
