The Regulatory Affairs Associate, Clinical Development is responsible for oversight of the regulatory submission process in support of Clinical Operations. The position supports the Clinical Development team in providing regulatory guidance and is an integral part of the Quality Improvement program. ***Based in Ohio or Salt Lake***
Responsibilities Liaison between Clinical Development and IRB/EC. Provide oversight of clinical trial submissions and continuing reviews:
- Responsible for initial study submission and protocol amendment submissions.
- Liaison between clinical research sites for the collection, review, and submission of essential documents.
- Track, report, and keep current submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable communication systems.
Responsible for informed consent template process. Responsible for managing clinicaltrials.gov submissions. Analyze regulatory information and provide guidance to applicable departments and individuals, as needed. Evaluate, update, and collaborate on applicable regulatory affairs policies, procedures, and training to ensure they reflect current regulatory requirements. Acquire and maintain an in-depth knowledge of the regulatory and ethics committee requirements (U.S. FDA Regulations and ICH Guidance's) for the level of development and type of research across all MGI products. Provide Regulatory Affairs support during internal and external audits. Assist in quality improvement (QI) and quality assurance (QA).
- Identification, implementation, and maintenance of QI and QA projects.
- Perform quality related tasks and manage the ongoing QA needs for Clinical Development.
- Perform document management related activities.
Qualifications Preferred Education/Credentials
- Bachelor degree in a scientific discipline.
- High School Diploma or equivalent and 6 years of clinical trial regulatory experience.
- Excellent written and oral communication skills.
- Ability to work independently and participate in cross functional team.
- Demonstrated problem solving skills.
- Excellent organizational and time management skills.
- Advanced working knowledge of Excel, Word, PowerPoint, and SharePoint.
- Experience in Medical Device and/or Laboratory Developed Test.
- Experience in quality management and/or quality assurance.
- In depth knowledge of ICH/GCP guidelines.
- High proficiency in regulatory submissions with IRB/EC.
- At least three years of direct clinical trial regulatory experience.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit; talk; or hear. The employee is occasionally required to stand; walk; use hands to finger, handle or feel; reach with hands and arms; and stoop; kneel; or crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision and depth perception.
About Our Company
Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: .
Myriad is an equal opportunity employer and as such, affirms in policy and practice to recruit, hire, train and promote, in all job classifications without regard to race, color, religion, gender, age, sexual orientation, gender identity, national origin, disability status or status as a protected veteran.
Reasonable accommodation will be provided for qualified individuals with disabilities and disabled veterans in job application procedures. We believe that diversity lends a regional, national, and global advantage to the clients we serve. Our workforce consists of dynamic individuals, with a range of backgrounds, talents, and skills.