Regulatory Specialist III

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Type of Position:
Professional Staff – Fiscal Affairs

Job Type:
Regular

Work Shift:

Sponsorship Available:

No

Institution Name:
University of Arkansas for Medical Sciences

The University of Arkansas for Medical Sciences (UAMS) has a unique combination of education, research, and clinical programs that encourages and supports teamwork and diversity. We champion being a collaborative health care organization, focused on improving patient care and the lives of Arkansans.
The safety of our team members at the University of Arkansas for Medical Sciences is our top priority. For this reason, successful applicants for this position must be fully vaccinated against Covid-19 or have an approved medical or religious exemption on file with our Student & Employee Health Services dept. UAMS will adhere to all federal, state and local regulations and will obtain necessary proof of vaccination prior to employment to ensure compliance.
 

UAMS offers amazing benefits and perks (available for benefits eligible positions only ):

• Health: Medical, Dental and Vision plans available for qualifying staff and family
• Holiday, Vacation and Sick Leave
• Education discount for staff and dependents (undergraduate only)
• Retirement: Up to 10% matched contribution from UAMS
• Basic Life Insurance up to $50,000
• Career Training and Educational Opportunities
• Merchant Discounts
• Concierge prescription delivery on the main campus when using UAMS pharmacy

Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening.  To apply for the position, please click the Apply link/button.

UAMS is an Affirmative Action and Equal Opportunity Employer  of individuals with disabilities and protected veterans and is committed to excellence.  If you need a reasonable accommodation for any part of the employment process, please contact us by telephone at (501) 686-6432 and let us know the nature of your request. We will only respond to messages left that involve a request for a reasonable accommodation in the application process. We will accommodate the needs of any qualified candidate who requests a reasonable accommodation under the Americans with Disabilities Act (ADA).

At UAMS we value Diversity, Equity and Inclusion. Visit our website to learn more: https://ddei.uams.edu/

For general application assistance or if you have questions about a job posting, please contact Human Resources at askrecruitment@uams.edu .

Department:
RESH Quality Assurance Unit

Department’s Website:

Summary of Job Duties:
The Regulatory Affairs Specialist (RAS) is expected to have excellent problem-solving, critical thinking, negotiation, and teamwork skills as well as excellent written and verbal communication skills. A successful candidate should be organized, able to multi-task, maintain a positive, helpful attitude, and take direction from Regulatory Affairs Manager (RAM). This position supports faculty who submit applications to FDA to obtain permission to study investigational drugs, biologics, and medical devices.
The primary tasks include preparation, submission, and maintenance of regulatory documents required for UAMS-sponsored IND/IDE applications and files. Applicants will be expected to assist with review of clinical research protocols, assuring that content meets the requirements of the U.S. Food and Drug Administration (FDA) and the UAMS Institutional Review Board (IRB). This position will require applicants to coordinate activities of investigators, other Office of Research Regulatory Affairs (ORRA) staff, and ancillary staff to achieve rapid and accurate project completion, meet deadlines and deliver detailed written reports as necessary.
In addition to initial FDA submissions, the RAS must understand pertinent regulations, manage adverse event reporting, handle annual reports, coordinate communication with FDA, and apply pertinent federal regulations to individual research proposals. The successful applicant will be expected to prepare and provide presentations; assist in the development of forms, templates, and project-specific documents; assist in the development of policies and procedures pertaining to regulatory matters and internal procedures.
UAMS has a unique combination of education, research, and clinical programs that encourages and supports teamwork and diversity. We champion being a collaborative health care organization, focused on improving patient care and the lives of Arkansans.
All UAMS employees will treat others with Dignity and Respect. We communicate and share complete and unbiased information, assuring our colleagues receive timely, complete, and accurate information in order make informed decisions. We participate in institutional initiatives and encourage the participation of others. We collaborate in policy and program development, implementation, and evaluation using best practices in delivering quality service. All duties will be performed in accordance with the UAMS Core Concepts of Patient and Family Centered Care set forth by UAMS. These core concepts allow for an approach to health care that shapes policies, programs, facility design and staff day-to-day interactions. It leads to better health outcomes and wiser allocation of resources, and greater patient and family satisfaction. The core concepts of patient and family centered care consist of Dignity & Respect, Information Sharing.

Qualifications:

Level III: Bachelor’s Degree (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) plus 5 years of experience in clinical research related to FDA Regulatory Affairs (e.g. IND/IDE, BLA/NDA/ANDA, PMA, 510(k), etc.) OR High School plus 9 years of experience in clinical research related to FDA Regulatory Affairs OR equivalent combination of education and experience

Level III – Responsibilities include all those of the RAS I and II as well as:
– Manage approximately 10-25 IND/IDE projects.
– Create and reviews CMC documentation for IND submissions for FDA.
– Assist RAM in the management of research studies involving novel investigational products, working directly with the investigator/inventor and CMOs and/or outside consultants to manufacture IDP and obtain stability testing results.
– Rely on in-depth experience and judgment to plan and accomplish goals.

Customer Service: Demonstrates effective communication skills; communicates accurate and complete information; maintains strict confidentiality when necessary. Demonstrates positive working relationships with co-workers, management team, and ancillary departments; follows the Core Concepts of Patient and Family Centered Care and the Basic Code of Conduct Guidelines. Assists internal and external stakeholders as needed with exceptional customer service. Interacts with and assists the public in a professional and friendly manner as needed.

Additional Information:

Salary Information:

Commensurate with education and experience

Required Documents to Apply:

Resume

Optional Documents:

Special Instructions to Applicants:

Recruitment Contact Information:

Please contact askrecruitment@uams.edu  for any recruiting related questions.

All application materials must be uploaded to the University of Arkansas System Career Site https://uasys.wd5.myworkdayjobs.com/UASYS  

Please do not send to listed recruitment contact.

Pre-employment Screening Requirements:
No Background Check Required

This position is subject to pre-employment screening (criminal background, drug testing, and/or education verification). A criminal conviction or arrest pending adjudication alone shall not disqualify an applicant except as provided by law. Any criminal history will be evaluated in relationship to job responsibilities and business necessity.  The information obtained in these reports will be used in a confidential, non-discriminatory manner consistent with state and federal law. 

Constant Physical Activity:
Walking

Frequent Physical Activity:
Talking

Occasional Physical Activity:
Hearing, Sitting, Standing

Benefits Eligible:
Yes